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Postings updated on October 2, 2018


Vice President of Regulatory Affairs/Quality Assurance

Predictive Technology Group, Inc.
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Salt Lake City, UT 84109
$120,000 a year

The VP of RA/CA will ensure worldwide regulatory strategies are clearly delineated, supported and implemented in the development, commercialization and life cycle management of the business’s Human Cell and Tissue Products (HCT/Ps).

The successful candidate will lead the development of global regulatory strategies and timelines for HCT/P product development projects, working through cross-functional teams to ensure that various pathways are examined early in the process. An assessment of the business risks associated with the preferred regulatory strategies, along with the mitigation plans must be presented to the project team and management in order to keep commercialization progress on track.

Contribute to the preparation and submission of domestic [510(k)s, Patient Registry, Institutional Review Board (IRBs), and Investigational New Drug (INDs) Studies] and international regulatory filings for the business group products in accordance with policies and procedures established by the company and regulatory agencies.

Job Functions

Vice President of RA/CA will be responsible for all regulatory and compliance responsibilities including:

  • Provide appropriate interface for the company’s HCT/P products with global regulatory agencies in a variety of pre- and post-market activities.
  • Provide guidance, interpretation and opinions on complex regulatory matters (particularly related to submission pathways), outlining the potential outcomes for different regulatory strategies. Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
  • Maintain active involvement in medical device and regulatory affairs organizations to ensure up-to-date knowledge of current and future industry trends.
  • Develop and maintain outstanding relationships with all regulatory and compliance activies with governing bodies.
  • Serve as liaison between governing bodies, the Food and Drug Administration (FDA), and other international regulatory submission agencies.
  • Lead regulatory due diligence assessments and recommendations for acquisitions and/or partnering and product distribution.
  • Spearhead the development and implementation of world class policies and procedures in conjunction with AABB, AATB, AdvaMed, ISO, ISCT and other governing bodies.
  • Ensure that HCT/P product labeling and promotional materials are in compliance with FDA, corporate, and international regulations and communicate the regulatory affairs strategy to the entire team and each key functional area to inspire proactive attention to this critical area within the company.
  • Provide technical leadership, training and vision by interpreting regulatory affairs initiatives and mandates, uncovering emerging trends and providing the processes necessary to meet rising acceptance of the company’s products.
  • Assist in the training of employees with regard to global regulatory requirements and regulatory affairs polices & procedures.
  • Provide timely information to the business unit and corporate management on issues and accomplishments, performance metrics and significant events.
  • Participate as a key member of the Product Development Team.
  • Assess the skills and competencies of the Regulatory Department, in alignment with the short and long term objectives of the various Predictive Business Groups.
  • Recruit, develop and retain professionals who demonstrate exceptional performance and leadership.
  • Ensure bench strength and succession planning through appropriate recruiting, staffing and development of team members.
  • Motivate, mentor and inspire department employees for success including goal setting, performance management, career planning and ongoing evaluation of both individual and department goals and control operational expenses in functional area of responsibility.
  • Actively participate in the preparation of overall expense budget and headcount forecast for Regulatory Department. Support company’s accounting functions while monitoring internal controls in accordance with internal policies and procedures.
  • Participate in internal or external audits.

Other duties as assigned.

Experience

  • Demonstrated track record of success in leading all areas of regulatory affairs for company that manufacturers OrthoBiologic or other HCT/P products.
  • Extensive knowledge and experience in designing regulatory and clinical strategies and submissions of product registrations HCT/P or Drug companies.
  • Minimum of ten (10) years of experience in a company with broad experience surrounding regulatory affairs.
  • A proven track record of building an effective regulatory affairs team.
  • Excellent analytical, interpersonal, and communication skills.
  • Ability to work well with senior management.

Preferred Experience

  • MD, DVM and/or PhD in biological sciences or other related field required.
  • Demonstrated track record of success in leading all areas of regulatory affairs for Orthobiologic, HCT/P or Drug Company.
  • Extensive knowledge and experience in designing regulatory and clinical strategies and submissions of product registrations for HCT/P or 351 Products.
  • Minimum of five (5) years of experience as a Director of Regulatory Affairs.
  • Past success operating in a large, matrix-managed bachelor’s or advanced degree in the physical sciences, biomaterials or related area.
  • Significant experience gaining regulatory approvals for HCT/Ps outside of the United States.

Salary

Salary is commensurate with experience. Full-time employees receive excellent benefits including: Medical, Dental, Group Term Life, Disability, Pension Plan Plus (401k and Pension Benefits), Flex-Spending, and other miscellaneous value-added benefits.

Equal Employment Opportunity Employer

Predictive Technology Group offers a highly competitive compensation plan with a benefits package.

Job Type: Full-time

Salary: $120,000.00 /year

Experience:

  • Regulatory Compliance: 10 years (Required)







Maverik Process Improvement Analyst

Job Title:               Process Improvement Analyst

Job Family:             Administrative

Job Group:             Information Technology

Reports To:            Director, Process Improvement & Compliance

FLSA Status:          Exempt

 Contact information: Elizabeth Benson, elizabeth.benson2@maverik.com

Summary:

The Process Improvement Analyst is responsible for executing a consistent, rapid and successful deployment of Continuous Improvement practices, developing continuous improvement plans addressing critical function needs, and identifying opportunities for improvement.  Additionally, the PI Analyst engages teams to adapt and maintain a lean continuous improvement culture while continually reviewing processes to eliminate waste in the business process. 


Essential Duties and Responsibilities:

  • Analyze and measure the effectiveness of existing business processes and develop sustainable, repeatable and quantifiable business process improvements
  • Collect and analyze process data to initiate, develop and recommend business practices and procedures that focus on enhanced safety, increased productivity and reduced cost
  • Create Process and Technical maps
  • Participate in searches for potential vendors when technical solutions to business problems are identified and work with the Procurement Team accordingly
  • Evaluate different process and/or documentation tools and provide appropriate recommendations
  • Research best business practices within and outside the organization to establish benchmark data
  • Track action items for implementing improvements, hold responsible parties accountable, and follow up through completion
  • Lead and perform Time studies and Root Cause Analysis (RCA) activities
  • Collaborate with business partners as needed to achieve results through process improvement
  • Determine how new information technologies can support reengineering business processes to make informed recommendations
  • Coordinate team activities to help in collaboration or project task completion
  • Additional responsibilities as assigned

Qualifications:  Experience, Competencies and Education

  • Bachelors degree or equivalent from a four-year College or technical school, or equivalent related work experience preferred
  • Ability to apply Lean SixSigma like methodology to Office and Retail settings
  • Excellent customer service and interpersonal skills
  • Experience with tools such as: MS Excel, Visio, Outlook, Ishikawa Cause-Effect, A3 and SIPOC
  • Desired specialization in one or more of the following areas: benchmarking, business process analysis and reengineering, change management and measurement, and/or process-driven systems requirements
  • Experience with documenting requirements or translating those into a Map or Process Flow
  • Ability to communicate with business and technical minded individuals

 Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  The noise level in the work environment is usually moderate.

 


Quality Manager


Hunter Douglas Fabrication Co
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Salt Lake City, UT

About the Company:

Beautiful design, industry-leading innovation, and a highly entrepreneurial global culture - all parts of your daily life at Hunter Douglas, the world’s leader in window fashions and maker of iconic architectural products.

Our nine-decade history has created a legacy of innovations and achievements. Most recently, we're pioneering exciting new digital technologies that transform stylish window treatments into intelligent smart shades for today's connected homes.

With the resources of a multi-billion dollar company and the energy and independence of a start-up, Hunter Douglas provides a unique entrepreneurial work environment in which passionate, creative, and cutting-edge thinkers can thrive.

About The Role- The Fabrication Quality Manager is responsible for:

  • Analyze data/trends on weekly Quality reports (CRR-Customer Reject Rate, IRW-Internal Rework, FR-Freight and ME-Manufacturing Escapes) and communicate results to the Plants/Division leadership
  • Lead Fabrication division analysis of Quality Alerts and the generated action items/investigations
  • Create prioritized RCCM improvement at each plant on CRR, IRW, FR and ME in conjunction with Plants/Division leadership that will ensure adherence to quality goals
  • Team up with CI Managers and lead coordination and tracking of progress on RCCM efforts (root cause analysis/training and project delivery) at each plant to ensure resolution of issue root cause, creation of proper countermeasures and putting the correct controls in place to prevent reoccurrence.
  • Create and facilitate the Fabrication division weekly Quality meetings to present progress on adherence to quality goals and countermeasures
  • Travel up to 50% of the time to audit Plants adherence to established Quality standards and Standard Work and to work with Plants to create countermeasures on gaps
  • Team up with other HD divisions (Raw Materials, Manufacturing Plants, Customer Relations) to collect and analyze data/feedback throughout the Value Stream that will aid in designing the quality into the products
  • Team up with Corporate Quality to improve Quality data collection systems/reports and to ensure adherence to Quality standards
  • Lead, as assigned, data analysis/Root Cause analysis projects that will aid the Plants and Division in meeting their Safety, Quality , Delivery and Cost targets
  • Engage, enhance, and fully execute the “Hunter Douglas Lean Management System”.
  • Lead continuous improvement through cross-functional team facilitation and project management that will lead to Fabrication division meeting the SQDC targets.
  • Drive the adherence of standard work/quality standards and ensures the integration with Lean Management System.
  • Act as primary liaison with Quality steering committees.
  • Network with other plant’s Lean/Quality leaders to leverage programs designed to continually improve operations and eliminate waste, fostering best practice and standardization.
  • Provide leadership by mentoring associates in the use of Quality tools, ensuring transfer of knowledge, and creating a culture of continuous improvement with quality in mind.
  • Collect and analyze the data on Plant processes, procedures and performance using evaluation tools and make recommendations on improvement quality-related opportunities/kaizens.
  • Establish collaborative relationship with local plant management.
  • Certify, train, and audit employees in use, understanding, and adherence to Standard Work quality-related specifications.
  • Review and train employees and management on use of problem solving, quality, and analysis tools.
  • Ensure processes are followed and consistent product quality is achieved according to internal specifications and external customer expectations.
  • Lead Root Cause Corrective Measures (RCCM) activities and quality improvement initiatives, in conjunction with operations/department management, Fabrication Engineering, and Hunter Douglas Brand Team, facilitating contact and follow-up with all support groups, i.e. IT, Maintenance, etc.
  • Monitor and implement corrective actions for internal (within Fabrication Division) and external (outside Fabrication Division) Quality by starting and participating in rapid improvement cycles.
  • Provide analysis on quality improvement to reduce/eliminate plant controllable errors.
  • Contributes to HD Lean Culture of continuous improvement, working with managers, supervisors, and employees, to identify improvement opportunities and implement corrective actions.
  • Effectively communicate with management, peers, shifts, support groups, other Hunter Douglas Divisions, and employees throughout the company.

QUALIFICATIONS

  • Bachelor’s Degree in Engineering (Quality or Industrial Engineering preferred) or related degree/diploma preferred
  • Six Sigma Certification (Green or Black Belt)
  • Minimum 3-5 Years of experience in a full-time Quality Control/Assurance Engineering/ Management role
  • Strong working knowledge of setting up quality standards, quality auditing, data analysis, Root Cause Analysis, gap management, improvement plan execution/management.
  • Strong Working knowledge of quality control/assurance systems and setting up and working with sampling plans/lot acceptance plans
  • Working knowledge of lean manufacturing principles and tools (e.g., value stream mapping, Kaizen, Charters, 5S, Gemba walks, LMS, root cause problem solving) to identify and develop solutions that drive operational improvement in Safety, Quality, Delivery and Cost.
  • Ability to plan, prioritize and organize work without close supervision
  • Ability to effectively handle multiple projects with track record of successful project completion
  • Computer and analytical skills required
  • Demonstrated ability to create and maintain strong business relationships
  • Ability to work independently, making sound decisions regarding daily functions/priorities while reporting non-routine decisions to Management
  • Strong analytical and interpersonal skills along with superior computer skills, i.e. SAP, BW, Excel, Word, PPTX, Minitab (or other statistical software).
  • Excellent communication and teaching skills, with a strong ability to rally employees and teams
  • Proven ability to adapt and manage effectively in a changing environment
  • Strong understanding of and commitment to manufacturing excellence
  • Must be precise with the highest focus on quality and the customer experience
Hunter Douglas Fabrication Co - 3 days ago - save job - report job - original job


Quality Validation Specialist


MasterControl
-
Salt Lake City, UT

About MasterControl

MasterControl Inc. creates software solutions that enable life science and other regulated companies to deliver life-improving products to more people sooner. The MasterControl Business Excellence Platform (BxP) accelerates ROI and increases efficiencies by automating and securely managing critical business processes throughout the entire product lifecycle. More than 1,000 companies worldwide, ranging in size from five employees to tens of thousands, rely on MasterControl BxP cloud solutions to automate processes for new product development, clinical, regulatory, quality management, supplier management, manufacturing and post-market surveillance. MasterControl solutions are well-known for being scalable, easy to implement, easy to validate and easy to use. For more information, visit www.mastercontrol.com.

SUMMARY

The Quality Validation Specialist is responsible for supporting the success of MasterControl's internal electronic Quality Management System (eQMS), which is comprised of, but not limited to customer feedback, document control, external audits, internal audits, improvement initiatives, quality events, management review, software validation, supplier management, and training. This position will also be responsible for sub-system administration duties with the MasterControl eQMS software and the review of MasterControl software validation documentation.

MasterControl produces eQMS software for companies in the Life Sciences and other regulated industries. MasterControl uses its own software to administer its internal eQMS. The eQMS is audited frequently by clients, notified bodies (ISO), and regulatory entities (FDA).

ESSENTIAL DUTIES & RESPONSIBILITIES

  • Review and provide essential feedback on software validation documentation (but this is not a software tester position). #WeWantRegulatoryExpertsNotSoftwareTesters
  • Oversee & act as sub-systems administrator for internal MasterControl production system. #WeLoveOurSoftware
  • Initiate/revise, collaborate, approve, and route internal procedures
  • Participate in facilitation of electronic employee training system
  • Complete customer quality audit questionnaires #WeLoveOurCustomers
  • Schedule and host on-site customer quality audits of MasterControl, Inc.
  • Participate in internal & external audits
  • Participate in local and cross-sectional improvement activities
  • Other duties as assigned by management

DESIRED SKILLS & EXPERIENCE

  • Bachelor's Degree in Communication, Life Sciences, Regulatory Sciences (or equivalent degree or experience) is preferred
  • Strong communication and writing skills are required.
  • The ability to work with a team but be self-motivated is required.
  • Integrity and accountability is required as the QMS is under constant scrutiny.
  • Experienced with Microsoft Office Suite (Word, Excel, Outlook, etc.) is required.
  • The ability to quickly learn new software applications is required.
  • Experience with MasterControl QMS Software is preferred.
  • Experience with Quality Management Systems (i.e. ISO 9001) is preferred.
  • Minimum of 2 years experience in Life Science industry.

PHYSICAL DEMANDS AND WORKING CONDITIONS

  • Ability to operate a computer and work at a desk for extended periods of time

Why Work Here?

#WhyWorkAnywhereElse

#ExceptionalTeamCulture

MasterControl is a place where Exceptional Teams come together to do their best work. Hiring Exceptional Teams, including the best talent in our industry, is a core value of ours. MasterControl employees are surrounded by intelligent, motivated individuals every day. We like to call it #TheBestTeamOnThePlanet.

We value every employee and their contribution to what makes MasterControl successful. We give right back to the employee through a generous benefits package, great flexibility, and continuous opportunities for advancement.

Not only do we hire Exceptional Teams, but we work hard to keep them here by developing and challenging their skillsets, encouraging professional development and growth, and offering a culture that can't be found elsewhere. Which is why we say - #WhyWorkAnywhereElse?

To put it simply, working at MasterControl is fun, challenging, and rewarding. From our Fitness Clubs to our awards programs, from our company parties to our competitive benefits, you can't really go wrong. MasterControl could be your next (and last) career move!

We are growing quickly and always looking for talented individuals to add to #TheBestTeamOnThePlanet!

Here are some of the benefits MasterControl employees enjoy:

  • Generous PTO package of three weeks, increasing after just three years of employment
  • Competitive compensation with annual merit increase reviews
  • 100% medical premium coverage (yes, you read that right!)
  • Dental/Vision Plans
  • 401k Plan
  • Employer Paid Life Insurance Policy ($50K)
  • Great Flexibility
  • Wellness Programs (every employee gets a Fitbit!)

Applicants must be currently authorized to work in the United states on a full-time basis


QA Manager

Wildworks - Draper, UT 



Job Description

WildWorks is seeking a motivated and energetic QA Manager who is detail-oriented and can help bring our games to life with an exceptional standard of quality.

Responsibilities
As an integral part of the team, you will work closely with many of our departments and leads including Producers, Software Engineers, Designers, and Artists. You will champion the culture of quality by improving processes and providing direction for our QA team. We are dedicated to automated testing and continue to pursue areas to improve coverage through automated testing. Your role will help define the roadmap to transition manual test coverage into automated tests.

Additional Tasks
Set priorities and remove roadblocks to make sure sufficient coverage is done for releases.
Design and author software test plans, test cases and design specs for software products.
Teach, mentor, and supervise QA Analysts & Testers. Qualifications

Excellent written and verbal communication skills
Superior work ethic
Exceptional attention to detail
4+ years of experience in Video Games Quality Assurance
Shipped at least 2 games as a QA Lead or QA Manager
Expert in authoring test cases, test plans and QA documentation
Expert at exploratory and creative testing
Knowledge working with Agile development processes
Knowledge of Jira, Google Suite, TestRail and Jenkins
A passion for video games

Additional Information

All your information will be kept confidential according to EEO guidelines. This is a full-time, salaried position in our Draper studio. No agents or third-party submissions, please.

Only candidates submitted through our career link will be considered.


Quality Assurance Supervisor

Corning
-
Salt Lake City, UT 84107

Corning is one of the world's leading innovators in materials science, with a 166-year track record of life-changing inventions. Corning applies its unparalleled expertise in glass science, ceramics science, and optical physics, along with its deep manufacturing and engineering capabilities, to develop category-defining products that transform industries and enhance people's lives. Corning Valor™ Glass is an example of a life-changing innovation purpose-built to store and protect injectable medicines. Corning is also a global leader in pharmaceutical tubing, manufacturing a variety of clear and amber glass tubing that is converted by our customers into vials, cartridges, ampules and syringes.

Scope of Position:

In this role you will be working with liquid handling disposable products for research labs in the biomedical industry and responsible for leading the Quality Assurance Lab operations and personnel. We look for you to lead the NCMR program, ensuring that corrective measures for quality issues meet acceptable reliability standards and corrective activities and documentation are aligned with requirements. You will also ensure compliance to regulatory requirements and lead incoming inspection activities.

Day to Day Responsibilities:

  • Supervision of quality technicians and executing supervisory roles such as, career development, hiring/terminations, and timecard review.
  • Provide training & coaching as appropriate.
  • Maintenance of lab equipment and testing methods, protocols, and equipment.
  • Lab supplies procurement.
  • Collaborates with engineering, manufacturing and management to ensure quality standards are in place.
  • Quality Plans and Product specifications.
  • Adequate testing and inspection methods and equipment plus acceptance criteria.
  • Exercises judgement within defined procedures and practices to figure out appropriate action.
  • Tracks and reports on metrics.
  • Leads process validation activities (IQ, OQ, PQ).
  • Collaborates with other divisional facilities for resources, information, assistance, etc.
  • Handles the liquid handling functionality testing lab personnel and operations.
  • Leads microbial testing and certification testing lab.
  • Handles quality related record retention.

Travel Requirements: up to 10% domestic.

Hours of work/work schedule/flex-time: M-F, standard business hours on first shift. Some overtime or weekend hours may be needed to support business needs.

Required Education:

  • Bachelor’s degree in engineering or science related field or equivalent.

Required Years and Area of Experience:

  • Minimum of 3+ years of quality assurance or quality engineering related experience with knowledge of ISO 13485 standard, requirements and certification or equivalent.
  • Prior supervisory or leadership experience leading others.
  • Hands on experience with validations, sample plans and measurements systems.
  • Familiar with quality and statistical tools such as, DMAIC, sampling, 5 WHY, fishbone, gauge R&R, MSA, etc.
  • Ability to identify root cause of problems to enable effective corrective actions.

Desired Experience / Qualifications / Skills:

  • Six SIGMA related certifications.
  • CQE certification.
  • APICS Certification.
  • Familiar with Quality Management Systems.

Soft Skills:

Do you have strong communication and interpersonal skills enabling you to interact positively with customers and team members and the ability to motive and influence change?

  • Do you work well within multifunctional groups?
  • Are you organized and have a strong attention to detail?
  • We are looking for you to be able to learn technical concepts quickly and have good analytical skills.

Quality Analyst Engineer-Stf

Intermountain Healthcare
-
Salt Lake City, UT
Description:

About Us
What does it mean to be a part of Intermountain Healthcare? It means that the quest for clinical excellence is not just a goal, but a given. It means building an environment where physicians and employees can deliver the best in healthcare. And it’s realizing each employee or volunteer is vital to the healing process, because we can only achieve the extraordinary together.

Being a part of Intermountain Healthcare means joining with a world-class team of over 36,000 employees and embarking on a career filled with opportunities, strength, innovation, and fulfillment. Our mission is: Helping people live the healthiest lives possible.

Our patients deserve the best in healthcare, and we deliver.

Job Description

Quality Analyst/Engineer-Staff is responsible to ensure software quality through testing software/software platforms for specific business needs including: enhancements, maintenance, and defect fixes. Staff-level professional experienced in all aspects of quality assurance and testing. Encompasses full knowledge required within the quality and software development lifecycle. Functions independently with minimal oversight and direction.

Essential Job Duties

  • 1. Creates and maintains test plans and individual test cases using approved standards, processes, and tools for common and moderately complex projects. Evaluates level of risk in determining the scope and coverage of the individual test plan(s).
  • 2. Executes test cases, accurately documents defects using approved standards, processes and tools for common and moderately complex projects.
  • 3. Collaborates in requirements development and/or review.
  • 4. Reports results and recommends to key business stakeholders/groups on the quality of the product, software development lifecycle processes and the risk of promoting for production use for common and moderately complex projects.
  • 5. Participates in the creation and management of project plans. Consistently meets agreed upon deadlines or escalates issues, concerns, and barriers to key project leaders. Assists in the prioritization of tasks/assignments.
  • 6. Acquires and maintains a moderate understanding of the technical and functional architecture, security, and compliance requirements of assigned systems and integration.
  • 7. Investigates and assists in the resolution of common and moderately complex issues, incidents, and problems. Collaboratively works with peers, internal and external stakeholders, and vendors.
  • 8. Participates in the development of training and knowledge based materials for use by peers and other IS team members.
  • 9. Creates and maintains moderately complex database queries.
  • 10. Creates and maintains automation scripts for common and moderately complex projects.
  • 11. Participates in the creation of test harnesses, automation, and performance testing frameworks.
  • 12. Acts as resource to Associate level team members
  • 13. Independently develops and implements communication plans to all stakeholder groups (internal and external).

Posting Specifics

  • Benefits Eligible: Yes
  • Shift Details: M-F, days
  • Department: Quality Assurance
  • Additional Details: This position will work for SelectHealth

Minimum Requirements

  • Bachelor's degree in an information technology, computer science, healthcare (clinical or business), or business related field, or four years of equivalent information system experience. Degree must be obtained through an accredited institution. Education is verified.
  • Three years of experience working in the information technology QA field.

Physical Requirements

  • Interact with others requiring the employee to communicate information.
  • Operate computers and other IT equipment requiring the ability to move fingers and hands.
  • See and read computer monitors and documents.
  • Remain sitting or standing for long periods of time to perform work on a computer, telephone, or other equipment.

Preferred Requirements

  • Demonstrated understanding of the basic concepts of healthcare or healthcare insurance. Understands the basic types of information used in a healthcare or healthcare insurance environment and how the data is produced, consumed, and transformed.
  • Experience in creation and maintenance of moderately complex database queries.
  • Experience in two or more programming languages.
  • Experience consistently delivering an extraordinary customer experience when interacting with peers, end-users, and others.
  • Strong written and oral communication skills with spoken English in a technical or healthcare environment.
  • Good interpersonal skills.
  • Ability to present ideas in user-friendly language.
  • Self motivated and directed.
  • Keen attention to detail.
  • Ability to effectively prioritize and execute tasks in a high-pressure environment.
  • Strong customer service orientation.