30 applicants

Company

Original Job Post

bioMérieux · 12 hours ago

Quality Engineer II/III-Instrument QA

Salt Lake City, UT

Full-time

Onsite

Senior Level

3+ years exp

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Biotechnology Research

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Comp. & Benefits

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Responsibilities

Perform all work in compliance with company policy and within the guidelines of its Quality System.

Lead investigations into product and material non-conformances (NCR), including problem identification, product & process quality risk assessment, root cause analysis, product disposition, remedial action, and the need for follow-up action.

Author non-conformance reports.

Coordinate investigation activities cross-functionally.

Ensure timely NCR processing.

Analyze data related to product non-conformities to identify trends and emerging issues.

Participate in technical review discussions as a QA representative.

Coach engineering and support teams on QA tools and processes.

Assist with equipment process validations and in-process test method validations.

Serve as a Quality representative for disposition and decision-making.

Communicate complex information both verbally and in writing.

Engage in managing quality risks associated with equipment and process changes.

Facilitate root cause investigations.

May lead teams with investigation methodologies and validation strategies.

Document notes, record and follow-up on action items, and communication to senior leaders as needed.

Manage small projects when assigned.

May study, develop and report Quality related metrics.

Qualification

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ISO standardsQuality assuranceQuality controlContinuous improvementQA toolsTechnical writingQuality risk managementStatistical calculationsMS OfficeProject managementTraining presentationsStandingComputer monitorsProblem-solvingCollaborationAttention to detailCommunicationMentoringLeadershipASQ CertificationCertified Six Sigma Green BeltCQE electromechanicalPneumatic components

Required

Bachelor's degree in a Science or Engineering discipline. Minimum ten years professional experience in a Quality Assurance, Quality Control, laboratory or life science or other manufacturing setting that has a formal quality system may be considered in lieu of a degree.

Understanding of good manufacturing practices, ISO 9001, ISO 13485, and/or 21 CFR 820 is required.

3+ years of experience in an Engineering, Scientific or Investigative role is required.

Experience in Quality Assurance, Quality Control, laboratory or life science or other manufacturing setting that has a formal quality system is required.

Application and use of Continuous Improvement and QA tools (Pareto, flow charts, Ishikawa, process capability, histogram, 8D, etc.) required.

Fundamental understanding of problem investigations (identification, scope determination, impact assessment, and remedial action)

Technical writing skills

Writing procedures, flowcharting

Ability to collaborate cross-functionally

Application of Quality Risk Management principles

Attention to detail (e.g., document reviews, investigation write-ups).

High level of written and verbal communications skills

Ability to communicate with Statisticians and perform statistical calculations as instructed

Proficiency in MS Office tools, including Outlook, Word, and Excel

Developing Trends and Measures

Project management skills

Creating and giving training presentations

Mentoring peers and leading groups

Must be able to lift at least 25 lbs. and may be required to lift up to 50 lbs.

Must be able to sit or stand for moderate amounts of time and look at computer monitors for an extended amount of time with or without accommodation.

Preferred

ASQ Certification (e.g., Certified Six Sigma Green Belt, CQE) a plus.

Familiarity with electromechanical and pneumatic components and systems is a plus.

Company

bioMérieux

Glassdoor

4.0

Pioneering Diagnostics A world leader in the field of in vitro diagnostics for 60 years, bioMérieux is present in 45 countries and serves more than 160 countries with the support of a large network of distributors.

Founded in 1963

Marcy-l'Étoile, Auvergne-Rhône-Alpes

10,001+ employees