Archived Career Opportunities

Below is a list of job postings that have expired - these listing are for your reference only.

 

Quality Engineer

North Ogden, Utah Composites Company seeking Quality Engineer (Full-time, salaried with benefits, B.S degree in chemical engineering, chemistry, or composite materials.) Other technical degrees considered. Quality Engineer certification desired or willing to obtain certification after hire. Minimum three years experience in materials quality assurance preferred. Experience in testing, statistics, process control or related areas also considered. Management experience or aptitude a plus.  Salary: $60,000 - $100,000 per year, DOE)

Please fax resume attention Linda at (801) 622-3809.  Position open until filled.

POSTED 11/27/2007

Regulatory Affairs Specialist

Rapidly growing medical device company with exciting new technology seeks Regulatory Affairs Specialist to assist with worldwide regulatory clearances.  Successful candidate will write, submit, and follow-up on Class II and III regulatory documents for orthopedic implants and instruments to the US, EU, Japan, and elsewhere.  Must have 3-5 years of 510(k) experience, understanding of CE and IDE/PMA process, and be comfortable with direct FDA contact.  Duties include project team, document review, risk management, and compliance activities.

Bachelors degree in tech field or equivalent required.  RAC helpful.  Must be organized, detail oriented, and a good writer.  Experience with ISO 13485 preferred.

Candidate may contact or send resume to:

Linda Lamoreaux (Amedica Corp. HR):  linda@amedicacorp.com , 801-583-5100 X115

POSTED 11/26/2007

QA Lab Coordinator

Sorenson BioScience, a leading manufacturer of liquid handling products, has an immediate opening for a Quality Assurance Lab Coordinator with a background in life science related fields. This position is responsible for organizing and managing the QA lab, personnel, and QA functions.   

Successful Candidates will have college education in Molecular Biology and/or related life science fields, and experience working in laboratory environment involved with molecular biological applications.  Prefer experience in areas such as PCR reactions, DNA extractions, Electrophoresis, cell culture, sequencing, robotics, lab automation, etc.

Successful candidates will also have experience in a supervisory role, have very strong communication and interpersonal skills, good organizational and analytical skills.

Other desired qualifications include:

-Familiar with ISO 9001
-Proficient in computer applications such as Microsoft Word, Excel, Access, Powerpoint and other laboratory related software:2000, GMP, etc.  Experience in production and quality assurance. Understanding of statistical analysis, lean manufacturing, design of experiments, etc. Experience in APICS (American Production and Inventory Control Society) or ASQ (American Society for Quality) principles and/or certifications.

Thanks again,
Jeff Dunn
Q.A. Director
Sorenson BioScience, Inc.
801-266-9334

POSTED 11/26/2007

QA Career Opportunity
at Groen Brothers Aviation!!
“Home of the Heliplane”

Position: Quality Inspector
Department: Quality Assurance
Reports To: Chief Quality Officer (CQO)
FLSA: Full Time, Non-Exempt (Hourly)
Typical Schedule: Monday -Thursday, 6:00A.M. - 4:30 P.M.
Summary: Performs tooling and product inspections and maintains calibration and tooling inspection systems; calibrates PME. May train and evaluate other personnel in the use of PME, preparation of reports, etc.

Education/Experience

Minimum: High school diploma or equivalent.
Desired: College level education.

Five or more years inspection experience in an aerospace environment, including three or more years running CMM's, Faro Arms, and/or Laser Trackers.

A comprehensive understanding of geometric tolerancing.

Familiarity with standard machine shop practices, welding, and bonding.

Working knowledge of NDT methods including Eddy Current and Pennetrant Inspection.

To apply, please visit our website at www.groenbros.com

Interested candidates are also welcome to contact HR directly at 801-478-3894

POSTED 11/19/2007

JOB PROFILE
DIRECTOR OF OPERATIONS
MOUNT PROSPECT, IL

Scope of the Job

This position, which is located in Mount Prospect, IL, reports to the acting Director of Operations.  Your basic role is to run the daily operations and deliver projects within the agreed specifications and timeline.  Additional responsibilities include:

  1. Overseeing and ensuring appropriate validation activities.
  2. Taking responsibility for business financials and site performance against financial plan.
  3. Planning for growth of the business.
  4. Ensuring the development of staff.
Candidate Requirements
  1. We seek a seasoned operations and logistics professional with a minimum of 8-10 years of clinical trial packaging and supply experience.  Prior experience supporting large global clinical trials is preferred. 
  1. Candidates should have solid industry and operational experience within the pharmaceutical/contract packaging environment.

  2. For the best fit, you must be customer service focused, possess drive and motivation and a “roll your sleeves up” mentality.  You must be dedicated to the success of the business, a strong team player, capable of working collaboratively with colleagues in all functions and have developed and provided effective leadership for a successful and well-respected distribution organization.
Contact information:

Tracy Wolfe, PHR
twolfe@zingaro.com
Vice President
21936 Briarcliff Dr
Briarcliff, TX 78669-2012
(512) 327-7277

POSTED 11/17/2007

JOB PROFILE
SR. SUPPLIER ENGINEER
MEDICAL DEVICE

The Company

A leader in the medical products industry with more than a century of quality service to its customers, focusing its business on innovative products in key surgical specialties, including hernia repair, hemostasis, orthopaedics and laparoscopy.

 
Scope of the Job

This position, located at company headquarters in Cranston, Rhode Island, reports to the Supplier Quality Assurance Manager.  Your basic role is to work with assigned suppliers to implement the requirements of the supplier quality management program.  Your duties include:  

Candidate Requirements

Contact information:

Tracy Wolfe, PHR
twolfe@zingaro.com
Vice President
21936 Briarcliff Dr
Briarcliff, TX 78669-2012
(512) 327-7277

POSTED 11/17/2007

Customer Relationship Manager
MasterControl Inc.
 
http://www.mastercontrol.com/company/customer_relationship_manager.html
 
http://www.mastercontrol.com/
 
1.   CRM Life Sciences - Med Device
2-5 years of Life Sciences experience in medical device marketing, quality, development and/or manufacturing processes.  Must have a basic understanding of GxP compliance issues and/or requirements.
Technical proficiency in IT systems that support development, manufacturing or quality is desirable.
2.  CRM Life Sciences - Blood and Biologics
2-5 years of Life Sciences experience in blood products or biologics.  Must have a basic understanding of GxP compliance issues and/or requirements.   Technical proficiency in IT systems that support donor processing, blood or tissue management, or quality is desirable.
 
  STATUS:
  HOURS:
  DAYS:
  .  Permanent
  .  Full-time
 
  .  8am-5pm
  .  Monday - Friday
 
The following information applies to both positions:
JOB SUMMARY:
The Customer Relationship Manager (CRM) role is a key function of the MasterControl Client Services Department.  The CRM will serve as the primary point of contact and the overall relationship manager for a number of MasterControl clients. The person will oversee all post-sale activities associated with the client,. The person will also be responsible for increasing customer loyalty, ensuring customer retention, engaging in proactive communication with customers, and resolving product/business issues experienced by the client. CRM owns the corporate relationship, and advocates for the customer within MasterControl by working in partnership with Sales, Marketing, Professional Services, Technical Support, and other departments to promote customer satisfaction
This person will also assist in identifying and anticipating the future life sciences, quality and compliance needs of the existing customer and matching those needs to MasterControl products and services.  The CRM will take an active role in working with sales on specific action plans to increase revenue.

 The CRM is measured against two goal categories, namely customer loyalty and account growth
Customer loyalty includes ensuring that:
  • The planned implementation achieves the intended customer goals
  • The customer is satisfied and is a potential reference
  • The customer keeps their Master Services Agreement (MSA) active
 Account Growth includes:
  • Assisting sales to grow the account with additional products and services.
  • Re-opening "expired" MSA
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Pre Sales
  • Support Sales and/or Marketing efforts to existing customers
  • Provide industry expertise to pre-sales process as requested
Customer Relationship Management
  • Facilitate a smooth transition from sales to customer service engagement.
  • Provide a single point of contact for customers on all activities associated with that customer
  • Oversee all post-sale activities associated with the customer including the timely delivery of all products and services
  • Coordinate service resource requirements.
  • Manage customer relationship through proactive methods
  • Regular communication with senior executives and Regional Sales Managers on account status
  • Measure and monitor ongoing customer satisfaction and identify and deliver programs to increase satisfaction when necessary
  • Take an active role in timely issue resolution and escalation. 
  • Coordinate with Technical Support to proactively plan for upgrades and to assist as needed with MSA collection
  • Provide valuable industry knowledge & expertise to customers
  • Work with customers to implement a validation strategy that will allow them to take advantage of upgrades, new product modules, etc.
  • Work directly with  Regional Sales Managers to ensure customer success and increased sales

QUALIFICATIONS
  • Proven track record in the area of customer relationship management
  • Professional and interpersonal skills required to develop and foster positive relationships
  • Proficient in the areas of web based applications and MS Office products
  • Outstanding communication skills (both verbal and written)
  • Excellent analytical, detailed oriented and possesses excellent organizational  and follow-up skills
  • Must be able to function under pressure to meet tight deadlines
  • BA or BS degree required in speciality areas, degree preferred in Standard otherwise equivalent experience.
  • 25%  travel required
  • Some sales experience is a plus.
  • PMP or other project management certification a plus.


For further consideration please submit resume to employment@mastercontrol.com

posted 11/07/2007

 

 

Senior Software Quality Engineering (REQ# 07-0745)

Position Summary
Responsible for ensuring that software used in the development, manufacturing and as part of medical devices is developed according to good design practices and follows the corresponding requirements set forth by local procedures, regulatory authorities and notified bodies.  Provide leadership, oversight and training to division manufacturing plants for computerized system validation. 

 

Essential Functions:
1.Promote a structured software development process. Assure that a state of control is maintained for in-house and outsourced software development.
2.Participate in critical analysis, design, and change review meetings for product and non-product software.
3.Provide oversight of manufacturing software validation process.
4.Generate metrics for assessing software quality and evaluate results.
5.Contribute to process improvements by developing and/or updating written company or departmental procedures related to software development.
6.Administer configuration control system for device, manufacturing and product development tools software.  Provide oversight during software release to manufacturing as well internal distribution.
7.Administer and control problem-tracking database and oversee defect process resolution.
8.Support outsourced software vendor audits and qualification.
9.Provide software validation, design controls, and risk management training.

 

Requirements:
Bachelor of Science degree in Electrical Engineering, Computer Science, or Computer Engineering
5+ years in software quality engineering role dealing with embedded software that is part of a medical device.
Working knowledge of the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive
Skilled in product risk assessment (ISO 14971), requirements management and tracing, defect tracking, configuration management techniques, and how they are applied in the software development lifecycle
Understand current Software Quality techniques, software industry standards (e.g. ISO, IEEE, CMMI), and FDA Quality System Regulations and their impact on internal procedures, software quality, safety and efficacy of products
Working knowledge of C, C++, and LabVIEW

Nellcor Puritan Bennett is now the Respiratory and Monitoring Solutions business unit of Covidien (formerly Tyco Healthcare).  Our systems are used to monitor, diagnose and treat respiratory disease and sleep disorders, and they provide life sustaining ventilation and oxygen support for patients.  In addition, to Respiratory and Monitoring Solutions, Covidien also manufacturers, distributes and services a diverse range of industry-leading product lines, including surgical devices, energy-based devices, pharmaceutical products, imaging solutions, patient care and safety products, and medical supplies.

Please apply online:   www.covidien.comcareers    Jobs are listed under Respiratory Solutions – Boulder, CO  

We offer relocation assistance and a competitive salary and benefits.

POSTED 11/04/2007

 

Software Quality Engineering Manager (REQ# 07-0621)

Essential Functions

• Oversee and manage Software Quality Assurance Engineers ensuring that software used in the development, manufacturing, and as part of medical devices is developed according to good design practices and follows the corresponding requirements set forth by local procedures, regulatory authorities and notified bodies. (e.g. FDA and TUV).
• Manage Manufacturing Software Quality Engineer providing oversight, review and approval of manufacturing division computerized system validations.
• Manage department resource allocation across multiple product lines.
• Write software process procedures and guidance documentation for software development lifecycle.
• Interact with FDA inspectors and auditing body agencies during audits.
• Drive change, demonstrate effective decision making, and provide direction for quality operations.
• Provide guidance and advancement opportunities for department employees.

 

Minimum Requirements

Bachelor of Science degree in Electronics Engineering, Computer Science, or Computer Engineering
6+ years experience in software test or software quality engineering with embedded software as part of a medical device
Experience in a management role
Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive
Skilled in product risk assessment (ISO 14971), requirements management and tracing, defect tracking, configuration management techniques, and how they are applied in the software development lifecycle
Understanding of current Software Quality techniques, software industry standards (e.g. ISO, IEEE, CMMI), and FDA Quality System Regulations and their impact on internal procedures, software quality, safety and efficacy of products
Working knowledge of C, C++
CSQE Certification

Nellcor Puritan Bennett is now the Respiratory and Monitoring Solutions business unit of Covidien (formerly Tyco Healthcare).  Our systems are used to monitor, diagnose and treat respiratory disease and sleep disorders, and they provide life sustaining ventilation and oxygen support for patients.  In addition, to Respiratory and Monitoring Solutions, Covidien also manufacturers, distributes and services a diverse range of industry-leading product lines, including surgical devices, energy-based devices, pharmaceutical products, imaging solutions, patient care and safety products, and medical supplies.

Please apply online:   www.covidien.comcareers    Jobs are listed under Respiratory Solutions – Boulder, CO  

We offer relocation assistance and a competitive salary and benefits.

POSTED 11/04/2007

 

Senior Software Quality Engineering
Positions Open in Boulder, Colorado and Carlsbad, CA

Position Summary
Responsible for ensuring that software used in the development, manufacturing and as part of medical devices is developed according to good design practices and follows the corresponding requirements set forth by local procedures, regulatory authorities and notified bodies.  Provide leadership, oversight and training to division manufacturing plants for computerized system validation. 

Essential Functions:
1.Promote a structured software development process. Assure that a state of control is maintained for in-house and outsourced software development.

2.Participate in critical analysis, design, and change review meetings for product and non-product software.
3.Provide oversight of manufacturing software validation process.
4.Generate metrics for assessing software quality and evaluate results.
5.Contribute to process improvements by developing and/or updating written company or departmental procedures related to software development.

6.Administer configuration control system for device, manufacturing and product development tools software.  Provide oversight during software release to manufacturing as well internal distribution.

7.Administer and control problem-tracking database and oversee defect process resolution.
8.Support outsourced software vendor audits and qualification.
9.Provide software validation, design controls, and risk management training.

Requirements:
Bachelor of Science degree in Electrical Engineering, Computer Science, or Computer Engineering
5+ years in software quality engineering role dealing with embedded software that is part of a medical device.
Working knowledge of the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive
Skilled in product risk assessment (ISO 14971), requirements management and tracing, defect tracking, configuration management techniques, and how they are applied in the software development lifecycle

Understand current Software Quality techniques, software industry standards (e.g. ISO, IEEE, CMMI), and FDA Quality System Regulations and their impact on internal procedures, software quality, safety and efficacy of products

Working knowledge of C, C++, and LabVIEW

Michelle Rawicz
Staffing Consultant
303.305.2462 (o)
michelle.rawicz@covidien.com
www.covidien.com/careers
Covidien
Respiratory and Monitoring Solutions unit
Nellcor/Puritan Bennett product lines

Please visit us and apply online at: www.covidien.com/careers our jobs are listed under "Respiratory Solutions" - Boulder, CO


posted 09/12/2007

Sr. Quality Engineer

Rapidly growing Salt Lake City medical device company seeks Sr. Quality Engineer.   Position will develop inspection and test protocols, design tooling and gages, recommend equipment, and oversee day-to-day inspection and testing of advanced ceramic orthopedic components.  

Masters degree in tech field and 10 years experience required.  QA experience with ISO 9000 or 13485 required. CQA, CQE, and/or CQM preferred.  Must be organized and detail oriented.  

Job Responsibilities:

 Develops inspection protocols, procedures and sampling plans, designs tooling or fixtures, and recommends necessary equipment or gages to perform incoming, in-process and final inspection on ceramic orthopedic components.  This includes assessing the physical and chemical properties of raw materials, and determining the visual and dimensional characteristics of work-in-process and finished goods.  Works closely with Product Development and Manufacturing groups to ensure quality requirements are clearly defined, communicated and documented.  Oversees and/or performs inspection and testing of materials and products to ensure adherence to these quality standards.  Analyzes inspection data, prepares summary conformance reports and recommends corrective actions as may be necessary. Responsible for the operation and maintenance of mechanical and analytical inspection and test equipment, and calibration records on all production and inspection equipment.  Leads and directs the work of others. 

 

Requirements:

Position requires a Masters degree in a relevant technical field with at least 10 years experience in quality engineering and control.  Candidate must have demonstrated capabilities in the development and implementation of inspection plans and protocols.  Must be familiar with the use of both common and advanced metrology equipment, including hand tools, gages, optical comparators, and coordinate measuring machines (CMM).  A sound understanding of Sampling Plans, Statistical Process Control (SPC) and Design of Experiments (DOE) is also necessary, as is prior experience working within ISO 9000 or ISO 13485 quality systems.  CQA, CQE and/or CQM candidates are preferred.  Must be organized and detail oriented. 

If interested please contact:

Ms. Linda Lamoreaux
Employee Administration
801) 583-5100 x115

POSTED 11/04/2007

 

Quality Manager at Hill Air Force Base

The Quality Control Manager is responsible for implementing a quality management program (QMP) that includes elements of the companies ISO 9000 family of standards at Hill AFB under the DOCAT contract. The QMP Manager is responsible for tracking overall quality operations and providing support and training to the Task Area Leads and working level personnel in Quality Assurance matters. Additionally, the Quality Control Manager is responsible for all quality related issues and for maintaining policies, procedures, and practices under the DOCAT contract. QC Task area leads have the ultimate responsibility for implementing quality policy and ensuring all contract personnel are aware of quality and safety issues related to contract performance. The Quality Control Manager is completely autonomous in managing Quality Control functions on a day-to-day basis. He interfaces directly with Corporate Quality Assurance on Quality Control implementation and work practices. "

If interested, please respond to one of the following:

Thomas Fessenden - fessendent@eaglesupport.com
    Quality/Safety Manager
    Eagle Support Services
    Senior Member ASQ
    785-240-1410

Gary Andres (Program Manager) - andresg@eaglesupport.com

Or apply online at www.eaglesupport.com

posted 09/12/2007