Career Opportunities
Quality and Validation Engineer
Job Code: MG0801
Description:
This position is responsible for oversight of validation, qualification, and testing activity of new platforms and processes. The incumbent initiates and lead process improvement efforts and applies six sigma and lean tools to critical business processes driving improvements across functional areas.
Minimum Qualifications:
- Bachelor’s degree in engineering, science, statistics program.
- 5 years experience in pharmaceutical, biotech and/or medical device industry with advanced training in statistical analysis tools
- Certified quality engineer, must be currently certified
- Strong lean manufacturing hands-on experience
- Certified Six Sigma green belt. Must have documentation of completed projects
Desired Qualifications:
- Master’s degree in engineering/science/statistics program
- 7 years experience in pharmaceutical, biotech and/or medical device industry with advanced training in statistical analysis tools
- Certified Six Sigma Black Belt. Must have documentation of completed projects
- Advanced lean manufacturing background and hand-on experience
Relocation assistance is available.
If you would like to be considered for this position,
please send a copy of your
current resume and salary expectations to:
resumes@corporatetalentadvisors.com
CORPORATE TALENT ADVISORS
P.O. Box 540137
North Salt Lake, Utah 84054
801-992-3515 (office)
801-725-8696 (mobile)
Our client is a leading biopharmaceutical company focused on the development of novel healthcare products, headquartered in Salt Lake City.
Field Service Manager
Job Description:
BSD is looking for a Manager of Field Service to manage the customer and field service functions of its products. This responsibility requires the person either be an electrical engineer or be highly trained and experienced in maintaining and servicing high technology medical electronic equipment. The position would require travel, including international travel, and completion and maintenance of required documentation for the products. It is preferred that the person have 10 years or more in employment experience with supporting or working with medical electronic systems and equipment. Understanding of medical equipment regulations, such as IEC 60601-1, is also desired. The person needs to able to communicate effectively with doctors, engineers, and physicists. The candidate will need to work with international service center training needs. The candidate have basic computer skill as well as experience with electronic test equipment.
/Contact:
Email: Dixie Sells
BSD Medical
The Wencor Group, located in Springville, UT, is a world leader in the aircraft parts industry. We have excellent opportunities for an ISO Quality Systems Manager and a Quality Engineer.
Wencor offers a comprehensive set of benefits including health, dental, life, and long-term disability insurance, paid time off, and a 401(k) retirement plan including a company match.
Please visit our website at www.wencor.com for application instructions.
ISO Quality Systems Manager (Springville, UT)
Essential Duties
- Manages all aspects of the implementation and continued compliance to International Standards Organization 9000 series requirements for all Aero Technologies Group sites.
- Maintains approval and continued compliance to aerospace industry dictated quality system requirements to include, but not limited to AS 9000, FAR Part 21, FAA AC-0056, CASE, ATA, and other major OEM contractual requirements.
- Manages quality system, which includes oversight of all related Quality Assurance Procedures, internal audits, customer audits and responses, root cause analysis and corrective action system, vendor qualification process, system related reporting metrics, and coordination of the management review process.
- Directs customer and supplier interface on quality related matters.
- Performs root cause investigation and analysis of product discrepancies.
- Performs as direct back up to the Quality Director in his/her absence.
Qualifications
- Minimum of five years of ISO quality system management and certified as an ISO / AS 9000 internal auditor.
- Active ASQ membership and/or related quality professional affiliations.
- Bachelor’s degree preferred with five years related experience; or equivalent combination of education and experience.
- Have clear vision (correctable to 20/25) at 14 inches and the ability to identify and distinguish colors in at least one eye.
- Previous aerospace quality system management experience preferred.
Quality Engineer (Springville, UT)
Essential Duties
- Provide the technical liaison between manufacturing and quality on all matters relating to quality systems, procedures, direction, processes, including Quality Assurance implementation and Maintenance.
- Responsible for activities related to the identification, tracking and resolving of all quality problems.
- Ability to coordinate metrology activity with requirements for manufactured parts.
- Provide technical liaison and consultation services for Manufacturing, Engineering, Sales and Purchasing to assure effective communication, coordination and interaction.
- Evaluate and develop quality requirements.
- Evaluate engineering designs to assure superior part quality.
- Participate in advance product feasibility assessment with affected company quality areas.
- Review and evaluate the adequacy of Control Plans and provide advice/assistance to obtain compliance.
- Provide Manufacturing and/or Engineering with Metrology information as needed.
- Provide assistance in performing capability studies and process potential studies.
- Participate in all customer quality audits.
- Review all safety and critical characteristics with engineering to reach mutual agreement on specifications.
- Develop and lead Advanced Product Quality Planning on newer modified products.
- Perform customer surveys and assist with supplier audits and evaluations.
- Assist quality manager develop and implement the Quality system.
- Monitor and assit manufacturing in process control and development.
- Must be able to travel up to 50%.
Qualifications
- Must have knowledge of quality techniques, methods and procedures.
- Knowledge of operational methods employed by Engineering, Manufacturing and Design preferred.
- Knowledge of current quality control methods, including statistical techniques.
- Possess a basic knowledge of company organization, policies and procedures
- Problem solving, PPAP, PSO, SPC, FMEA, Control plans.
- Basic understanding of Six Sigma performance measures and Lean Manufacturing concepts.
- Ability to evaluate and interpret complex specifications and blueprints.
- Proficient in Microsoft programs such as Excel, PowerPoint, Visio, and Access.
Education
- Bachelor’s degree in the Sciences, business, or other technical fields and four years of related experience preferably in the aerospace or automotive industry.
- Certification in ASQ CQI (fomerly CMI), ASQ CQE, or ASQ CQA preferred
POSTED 05/21/2008
Quality Engineer
ATI Wah Chang is part of the Allegheny Technologies Incorporated group of specialty metal manufacturers. Wah Chang, an AS9100 certified company, produces a line of metal products that include zirconium, titanium, hafnium, niobium, tantalum, and vanadium for the nuclear, aerospace, medical and chemical industries. This position is a quality engineer at a new titanium sponge plant currently under construction in Rowley, UT.
Position Responsibilities
The Quality Engineer will manage the day to day activities of the quality assurance program to ensure continuous production of product consistent with established standards. The Quality Engineer is responsible for interfacing with and providing technical assistance to customers and is the primary contact for all visitors such as auditors and source inspectors. They are also responsible for the development of new manufacturing processes to reduce costs, improve quality, and reduce cycle time. Specific duties will include: writing process instructions, reviewing customer P.O.’s and specifications, providing technical assistance to customers or potential users, performing process audits, recognizing and reporting process deviations, and assisting with diagnosis and correction of process/quality problems.
Minimum Qualifications:
Requires BS, preferably in Metallurgical, Mechanical, or Chemical Engineering. Must have a strong aptitude for applying engineering and quality principles in solving manufacturing issues. Quality Engineers must have sound judgment and be able to plan, organize and control multiple activities. Excellent communication skills (written and verbal) and the ability to interact well with employees and customers are essential. Proficient computer skills, creativity and innovation are a requisite. Ability to obtain a DOE Security Clearance is required. A minimum of four years experience and a technical background in heavy industrial engineering, familiarity with fundamental titanium metalworking processes or experience in a manufacturing environment is preferred.
Because we are a federal government contractor, we have special restrictions placed on us for hiring foreign nationals into certain key positions within the company. This particular position requires U.S. citizenship. Please be advised that employment with Wah Chang will be at will, and that it may be terminated by you or by the company at any time and for any reason, with or without notice.
Wah Chang is an AA/EEO employer and this position is open to all qualified individuals without regard to race, color, national origin, religion, sex, age, or disability.
Interested applicants may email to Jobs@WahChang.com,
subject: Utah Quality Engineer
or by US mail to ATI Wah Chang - Attention HR, PO Box 460, Albany, OR 97321.
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ALLOSOURCE POSITION DESCRIPTION
Position Title: |
Department: |
Reports To: |
Date Prepared/Revision Date: |
Exempt/Non-Exempt: |
Location: |
EXPERIENCE REQUIRED FOR THE POSITION:
At least 3 years working in a FDA regulated industry (ex: tissue banking, medical device, biologics or pharmaceutical) in a quality role. Experience shall include direct experience with aspects of a Quality System. This includes but is not limited to; quality assurance, quality control, document control, regulatory affairs (auditing, regulatory compliance, incident reporting, inspections, submissions, data review, recalls, etc.). This position requires excellent written and communication skills.
EDUCATION REQUIRED FOR THE POSITION:
A Bachelors degree in a technical or scientific field or five or more years experience in a quality assurance role in a FDA regulated industry.
POSITION DUTIES:
- Administer and coordinate quality system processes (Incident Reports, CAPA, PER).
- Conduct internal audits according to the standard operating procedure
- Organize and facilitate meetings.
- Maintain databases and follow up on action items.
- Develop, implement, and maintain procedures in support of the Quality Systems.
- Assist with registrations, licensure, and submissions.
- Conduct regulatory research.
- Represent quality and provide guidance for day-to-day issues.
- Perform other RA/QA activities as required or assigned.
Interested applicants may email a resume to resumes@allosource.org or fax to 720-873-0212.
POSITION DESCRIPTION
Title: Senior Software Quality Engineer
Location: Denver, CO (Tech Center)
Relocation: Assistance provided
SUMMARY
This is an exciting opportunity to join a rapidly growing medical device industry leader. Our client is a successful and rapidly growing Denver area medical device company. Employee quality of life is one of our client’s core values, right alongside sustained profitability and customer loyalty. Their staff is what really sets them apart from the competition. They recognize that an organization's people are its most valuable asset, and have made concerted efforts to provide their employees with a career home. And the biggest incentive they offer is the opportunity to be part of a true team - a team made up of the most talented individuals in the industry, possessing unparalleled depth and breadth of experience.
We are seeking a Senior Software Quality Engineer to provide technical support, leadership, guidance, and discipline to the New Product Development Center of Excellence (COE) for Software Quality with specific emphasis in the areas of Software Quality Assurance, Regulatory Compliance, Product Reliability, Design Controls and other Quality Systems Requirements. The Manager will lead and manage software V&V and Design Control activities for New Product Development. What makes this opportunity so exciting? The company’s growth and future plans for a public offering and a terrific corporate culture for starters. World-class incentive and benefits will be offered to the successful candidate.
Essential Functions:
- The Voice of Software Quality in New Product Development.
- SQA test management.
- Establishment and management of measurable goals and objectives for a Software Quality Engineering staff.
- Leader, trainer, coach and mentor within the Software Quality Organization and throughout the company. At this level, high expectations are placed on leadership capacity and performance within that capacity.
- Understanding of food and drug laws, regulations, and practices, and accurately transmit them into procedures, programs, and behaviors to ensure that our client is at the forefront of regulatory compliance.
- Measurably and vigorously engage in making our client’s product quality better.
Duties/Responsibilities to accomplish Essential Functions:
- Demonstrated ability to create and manage an effective SQA program.
- Thorough understanding of FDA Design Controls with emphasis on software development.
- Thorough knowledge of FDA QSR requirements.
- Ability to write and execute effective and FDA compliant Software testing protocols to ensure that the medical device or application under test performs according to established specifications.
- Ability to manage the above.
- Have a thorough understanding and thorough experience with software testing methods.
- Experience in evaluating risk through formal risk analysis, PFMEA, FMEA, fault tree analysis, and other recognized tools.
- Ability to write and execute customer validation protocols.
What Our Client Gets Excited About
- Smart people who can think of more than one way to solve a problem.
- Demonstrated ability and desire to work in a true team environment. Must be able share your toys with others in the sandbox.
- People with stable and reliable work histories. People who have developed friends and relationships at previous companies.
- People who have career potential.
- People who not only like to do it but like teachings others how to do it.
- Effective communicators.
What You Should Get Excited About
- You’ll work with interesting people who have lives that extend beyond work.
- Your career advancement is limited only by your ambition and desire.
- You will know company objectives, company financials and have the ability to participate in setting both.
- Participate in a company undergoing aggressive growth, offering the many personal and professional opportunities that growth offers.
- Opportunity to make a real difference.
EDUCATION
- A Bachelor’s degree in software engineering or equivalent.
Contact: Greg Ambrose
Managing Director
Catalyst Search Group
888.598.4440 ext. 101 (toll free)
greg@cooltechjobs.com
POSITION DESCRIPTION
Title: Senior Quality Engineer, New Product Development
Location: Denver, CO (Tech Center)
Relocation: Assistance provided
SUMMARY
This is an exciting opportunity to join a rapidly growing medical device industry leader. Our client is a successful and rapidly growing Denver area medical device company. Employee quality of life is one of our client’s core values, right alongside sustained profitability and customer loyalty. Their staff is what really sets them apart from the competition. They recognize that an organization's people are its most valuable asset, and have made concerted efforts to provide their employees with a career home. And the biggest incentive they offer is the opportunity to be part of a true team - a team made up of the most talented individuals in the industry, possessing unparalleled depth and breadth of experience.
Essential Functions
- The Voice of Quality in New Product Development.
- Engineering test management. Applies advanced knowledge and analytical skills to assignments of diverse scope and complexity. Leads small teams within projects of moderate scope and complexity.
- Leader, trainer, coach and mentor within the Quality Organization and throughout the company. At this level, high expectations are placed on consensus building skills and integrating department objectives into personal objectives and work plans.
- Understanding of food and drug laws, regulations, and practices, and accurately transmit them into procedures, programs, and behaviors to ensure that our client is at the forefront of regulatory compliance.
- Promotes high standards of reliability in product offerings. Probes beyond the stated issue for the underlying causes.
Duties/Responsibilities to accomplish Essential Functions:
- Manages and performs V&V and process validation testing. Demonstrates commitment to project team results and assists other team members in meeting their goals. Contributes to project planning process. Adjusts to multiple demands and shifting priorities.
- Provides leadership and guidance in the area of Design Control.
- Interprets data and provides judgment to influence decisions. Effectively communicates complex information throughout organization, both verbally and in writing.
- Have a thorough understanding of product and process validation, gauge R&R, measurement capability methods, and failure analysis. Act as a liaison between new designs and shop floor implementation.
- Have a thorough understanding of human factors engineering.
- Experience in evaluating risk through formal risk analysis, PFMEA, FMEA, fault tree analysis, and other recognized tools.
- Understands and demonstrates relationship between patient safety and project responsibilities.
- Act as the Voice of Quality on cross functional teams.
- Authors Quality System procedures used to run the company.
- Evaluates, selects, and applies standard engineering practices.
What Our Client Gets Excited About
- Smart people who can think of more than one way to solve a problem.
- Demonstrated ability and desire to work in a true team environment. Must be able share your toys with others in the sandbox.
- People with stable and reliable work histories. People who have developed friends and relationships at previous companies.
- People who have career potential.
- People who not only like to do it but like teachings others how to do it.
- Effective communicators.
What You Should Get Excited About
- You’ll work with interesting people who have lives that extend beyond work.
- Your career advancement is limited only by your ambition and desire.
- You will know company objectives, company financials and have the ability to participate in setting both.
- Participate in a company undergoing aggressive growth, offering the many personal and professional opportunities that growth offers.
- Opportunity to make a real difference.
pOSITION rEQUIREMENTS
Required
- 5+ years relevant professional experience required
- Through understanding of the regulations and its impact on products, with Medical device and FDA experience.
- Effective project and time management skills to handle multiple projects and complete assignments with a minimal supervision.
- Expert knowledge in the application of consensus standards and methodologies related to medical devices and engineering tests.
- Excellent technical and business writing skills for plans, protocols, and reports.
- Practical experience with the risk management and design control processes.
- Ability to influence decision and work effectively in cross-functional teams.
EDUCATION
- A Bachelor’s degree in software engineering or equivalent.
CONTACT
Greg Ambrose
Managing Director
Catalyst Search Group
888.598.4440 ext. 101 (toll free)
greg@cooltechjobs.com
POSITION DESCRIPTION
Title: Software Quality Assurance Manager
Location: Denver, CO (Tech Center)
Relocation: Assistance provided
SUMMARY
This is an exciting opportunity to join a rapidly growing medical device industry leader. Our client is a successful and rapidly growing Denver area medical device company. Employee quality of life is one of our client's core values, right alongside sustained profitability and customer loyalty. Their staff is what really sets them apart from the competition. They recognize that an organization's people are its most valuable asset, and have made concerted efforts to provide their employees with a career home. And the biggest incentive they offer is the opportunity to be part of a true team - a team made up of the most talented individuals in the industry, possessing unparalleled depth and breadth of experience.
We are seeking a SQA Manager to provide technical support, leadership, guidance, and discipline to the New Product Development Center of Excellence (COE) for Software Quality with specific emphasis in the areas of Software Quality Assurance, Regulatory Compliance, Product Reliability, Design Controls and other Quality Systems Requirements. The Manager will lead and manage software V&V and Design Control activities for New Product Development. What makes this opportunity so exciting? The company’s growth and future plans for a public offering and a terrific corporate culture for starters. World-class incentive and benefits will be offered to the successful candidate.
Essential Functions:
- The Voice of Software Quality in New Product Development.
- SQA test management.
- Establishment and management of measurable goals and objectives for a Software Quality Engineering staff.
- Leader, trainer, coach and mentor within the Software Quality Organization and throughout the company. At this level, high expectations are placed on leadership capacity and performance within that capacity.
- Understanding of food and drug laws, regulations, and practices, and accurately transmit them into procedures, programs, and behaviors to ensure that our client is at the forefront of regulatory compliance.
- Measurably and vigorously engage in making our client’s product quality better.
Duties/Responsibilities to accomplish Essential Functions:
- Manage a SQA Team.
- Demonstrated ability to create and manage an effective SQA program.
- Thorough understanding of FDA Design Controls with emphasis on software development.
- Thorough knowledge of FDA QSR requirements.
- Ability to write and execute effective and FDA compliant Software testing protocols to ensure that the medical device or application under test performs according to established specifications.
- Have a thorough understanding and thorough experience with software testing methods.
- Experience in evaluating risk through formal risk analysis, PFMEA, FMEA, fault tree analysis, and other recognized tools.
- Ability to write and execute customer validation protocols.
What Our Client Gets Excited About
- Smart people who can think of more than one way to solve a problem.
- Demonstrated ability and desire to work in a true team environment. Must be able share your toys with others in the sandbox.
- People with stable and reliable work histories. People who have developed friends and relationships at previous companies.
- People who have career potential.
- People who not only like to do it but like teachings others how to do it.
- Effective communicators.
What You Should Get Excited About
- You’ll work with interesting people who have lives that extend beyond work.
- Your career advancement is limited only by your ambition and desire.
- You will know company objectives, company financials and have the ability to participate in setting both.
- Participate in a company undergoing aggressive growth, offering the many personal and professional opportunities that growth offers.
- Opportunity to make a real difference.
pOSITION rEQUIREMENTS
Required
- 5+ years relevant professional experience required
- Through understanding of the regulations and its impact on products, with Medical device and FDA experience.
- Effective project and time management skills to handle multiple projects and complete assignments with a minimal supervision.
- Expert knowledge in the application of consensus standards and methodologies related to medical devices and engineering tests.
- Excellent technical and business writing skills for plans, protocols, and reports.
- Practical experience with the risk management and design control processes.
- Ability to influence decision and work effectively in cross-functional teams.
EDUCATION
A Bachelor’s degree in software engineering or equivalent.
CONTACT
Greg Ambrose
Managing Director
Catalyst Search Group
888.598.4440 ext. 101 (toll free)
greg@cooltechjobs.com
MOOG.com
Moog Inc., a world class designer and manufacturer of precision control systems, has immediate openings in its Salt Lake City facility. Recognized in Fortune Magazine's inaugural list of The 100 Best Companies To Work For In America, Moog offers an outstanding work environment, competitive salary and fringe benefits. We are looking for uniquely qualified individuals with an interest in control systems and an intense desire to be the best in the world!
Quality Engineer
This position is responsible for identifying opportunities that will benefit A&T and manufacturing in terms of design optimization and product variation assessments in an environment with electronic focus.
Duties / Responsibilities
- Perform and support engineering system audits as well as internally scheduled engineering process audits
- Lead all aspects related to quality on specific assigned programs
- Provide technical support to customers, suppliers and government agencies to guarantee continuing positive and constructive relationships, and to keep them informed and ensure contract compliance on quality issues
- Work on complex problems where analysis of situations or data requires an in-depth evaluation
- Exercise independent judgment in developing methods, techniques and evaluation criteria for obtaining results
- Analyze contractual requirements; create program plans, procedures, quality codes, etc.
- Complete trend and reliability analysis and associated presentations
Education / Experience
- Possess a technical Bachelors degree or equivalent experience
- Previous experience working in a quality related environment, typically acquired with a minimum of six years experience
- Previous experience in a quality systems audit role required
Skills / Knowledge
- Electronics and mechanical experience preferred
- Possess a working knowledge of quality assurance with an extensive perspective of manufacturing, engineering, and procurement
- Strong analytical problem solving skills
Send resume to semployment@moog.com. Please note QE #A0411 in the subject line
Quality Manager
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Validation Manager
Nelson Laboratories, Inc. is a contract Microbiology testing lab. We help the best companies in the world improve the quality of life by providing the highest standard in laboratory testing. We work with some of the top medical device and pharmaceutical companies in the world, including many fortune 500 companies.
We currently have an opening for a Validation Manager. Hours are Monday – Friday 9AM to 5PM.
Responsibilities include:
- Delivery of validation services as support for the laboratory, functioning as the technical process validation expert; ensuring lab processes are validated in accordance with established regulations and approved quality standards and procedures; including development of validation master plan, document generation and protocol execution.
- Organize and prioritize a validation schedule with quality, timeliness, efficiency, and support as the criteria.
- Demonstrate efficiency in addressing the labs key initiatives.
- Represent the Validation Department on project and management teams and provide consultation and support as required.
- Implement new technologies and industry standards by determining acceptance criteria and developing validation protocols for the validation of facilities, utilities, computers, cleaning, equipment and change control administration.
- Responsible for the design, implementation and execution of strategic and operational objectives pertaining to validations.
- Develops strategies and metrics to improve throughput and to decrease quality system cycle time.
- Accountable to hire and maintain a high level of qualified and competent staff. Responsible for professional development of staff and performance management process.
- Oversee proficiency testing, control charts, and estimated uncertainties.
- Oversee the QC of incoming materials and supplies.
B.S. and 4 years applicable laboratory experience OR B.S. in science and 3 years applicable laboratory experience OR B.S. in Biology or Microbiology and 2 years applicable laboratory
experience. The following training highly recommended,
- ASQ certification
- Supervisory Training
- Business Training
- Other job specific certifications
- M.S. or Ph.D. in a biological science
- M.B.A.
Full-time position includes a complete benefits package. Nelson Laboratories, Inc. is an Equal Opportunity Employer. Salary is commensurate with education and experience. Interested applicants apply on line at www.nelsonlabs.com or in person at 6280 S. Redwood road.
POSTED 03/03/2008
Regulatory Auditor
Nelson Laboratories, Inc. is a contract Microbiology testing lab. We help the best companies in the world improve the quality of life by providing the highest standard in laboratory testing. We work with some of the top medical device and pharmaceutical companies in the world, including many fortune 500 companies.
We currently have a full-time position in our Quality Department for a Regulatory Auditor. Hours are 9 AM to 5 PM with some flexibility
Responsibilites include:
- Perform internal audits (GLP, GMP and ISO) and log book audits.
- The ideal candidate will possess excellent verbal and written communication skills and have working knowledge of federal and international regulations (GLP, GMP, ISO 9001, ISO 17025).
Qualifications: High School Diploma or Equivalent and four years applicable experience OR B.S. in Biological science with one year applicable experience. CQIA certification preferred.
Full-time positions include a complete benefits package. Nelson Laboratories, Inc. is an Equal Opportunity Employer. Salary is commensurate with education and experience. Interested applicants apply on line at www.nelsonlabs.com or in person at 6280 S. Redwood road.
POSTED 03/03/2008
Quality Investigator
Nelson Laboratories, Inc. is a contract Microbiology testing lab. We help the best companies in the world improve the quality of life by providing the highest standard in laboratory testing. We work with some of the top medical device and pharmaceutical companies in the world, including many fortune 500 companies.
We currently have a full-time position available for a Quality Investigator. Hours are Monday through Friday 8/9:00AM to 5/6:00PM
Responsibilities include:
- Acting as a quality representative for a specific section of the laboratory.
- The position involves identifying, analyzing, and applying scientific evidence to support decisions to validate or invalidate data, retest, or report with quality events.
- Applicant must have strong knowledge of microbiological procedures. This includes review of final GLP reports, GLP audits, and Quality initiatives.
Position requires Science B.S. (Microbiology strongly preferred) with 2 - 4 years laboratory experience desired. Salary is commensurate with education and experience.
Full-time positions include a complete benefits package. Nelson Laboratories, Inc. is an Equal Opportunity Employer. Salary is commensurate with education and experience. Interested applicants apply on line at www.nelsonlabs.com or in person at 6280 S. Redwood road.
POSTED 03/03/2008
Medical Device QC Engineer/Manager
Ceramatec and its affiliates are looking for a medical device quality
engineer and/or manager. This employee will play an important role with
significant responsibility for successfully developing with
cross-functional input, policies and procedures to establish our Quality
System (QS). This position will serve as a key driver for our QS to be
compliant with US FDA and ISO 13485 regulations, as well as serve the
business needs of the company. Assist in the 510K submission process and
development and implementation of quality procedures in support of
medical device research, development, and production.
Responsible for document management systems for: 1) establishment and
change control of internal quality procedures and records, 2)
maintenance of certain quality records (DHF and others), 3) library of
external standards which may apply to company and/or company products,
4) library of trade publications and medical journals.
Create and be responsible for internal and external audit program.
Create and implement audit schedule to ensure key suppliers and all
elements of QS are assessed on a regular basis. Create and be
responsible for corrective and preventive action (CAPA) program. Salary
is dependent upon qualifications and experience. Send resume to
jsteppan@ceramatec.com
POSTED 03/03/2008
Master Job Title: Regulatory Affairs Associate II
Location: Edwards Research Medical
6864 S. 300 W.
Midvale, UT 84047
Group/Function: Regulatory Affairs
Edwards Research Medical is a dynamic unit of Edward Lifesciences Corporation’s cardiovascular business, a global leader in the development, manufacture and supply of cardiovascular products and services. We currently seek an accomplished professional to contribute to our team:
*Multi-level position: Position title and level posted is preferred; however, will consider hiring at the Regulatory Affairs Associate level.
Description/Responsibilities: Represent Regulatory Affairs on new product development and production teams. Construct IDEs, PMAs, annual reports, 510(k)s and CE mark design dossiers. Assume regulatory review of labeling, product and process changes and product documentation. Act as liaison with government officials in support of product approvals.
Required Experience: Requires two years experience, preferably in medical device industry. Experience in constructing product submissions is required. Experience with Class II medical devices, cardiovascular devices, critical care, and vascular surgery devices is a plus.
*Regulatory Affairs Associate I requires a minimum of one year of experience in the medical device industry. Regulatory Affairs Associate III requires a minimum of four years of experience in the medical device industry.
Required Education: Bachelor’s degree is required; preferably in a life science or related field.
Special Requirements: Requires familiarity with new product development systems, a good working knowledge of all U.S. regulations that affect Class II devices, excellent writing and verbal communication skills, and strong problem-solving and analytical ability. Strong reading and comprehension skills are necessary. Excellent organizational skills, independent thinking, and a high level of initiative are a must. The ability to work well independently and as a member of a team is essential. Solid knowledge of medical terminology, ability to multi-task and prioritize work, and basic computer skills are essential.
As a global leader dedicated to building the best team in healthcare, Edwards offers a dynamic working environment with competitive compensation and full benefits. We make a difference in the lives of others and invite you to join us. Edwards is committed to a diverse workforce EOE.
HR Contact: Jacobsen, Tyler R.
Phone: 801/565-6286
Fax: 801/565-6177
E-Mail: Tyler_Jacobsen@Edwards.com
POSTED 03/03/2008
Quality Complaint Handler **** Immediate Need
Quality Engineer (Mfg Support)
Quality Engineer (R&D Support)
Quality Auditor
Regulatory Affairs Associate II
Sr Cost Accountant
SNE:
Administrative Assistant
http://www.edwards.com/careers/
POSTED 03/03/2008
Quality/Manufacturing Engineer or ME Manager
Celio (a very new startup with VC funding) is looking for a Quality/Manufacturing Engineer or ME Manager here in SLC. They are at www.celiocorp.com.
POSTED 02/06/2008
PEOPLE HELPING PEOPLE
job OPPORTUNITY
Job Title |
Client Services Coordinator |
Date Posted |
1/5/08 |
Reports to |
Kayleen Simmons, Executive Director |
DESCRIPTION
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Customer Service, 20 - 25 hours per week, with at least one weeknight evening per week and one Saturday morning per month
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DUTIES |
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Interested applicants: Please email resume to: ksimmons@phputah.org POSTED 02/06/2008 |
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