Quality Engineer - Systems

United States·Hazelwoodmid

EngineeringQuality Engineer

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Quick Summary

Overview

Position SummaryEnsures, through global and local Product Development Process procedures and efforts, that System/Instrument products are developed, tested and transferred to manufacturing according to established procedures that will assure that they meet all quality requirements.

Technical Tools

excelms-office

Requirements

~1 min read

Bachelor degree in an Engineering, Life Sciences or related field with 5 years experience of R&D Quality Assurance of Medical Devices or IVD's

9+ years experience of R&D Quality Assurance of Medical Devices or IVD's in lieu of degree
Demonstrated competence in the selection and use of Quality Engineering tools, techniques, and processes as pertaining to In Vitro Diagnostic System development as well as the ability to identify development process weaknesses and/or develop and recommend process improvements/best-practice.
Expert knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, IVDR, QSR, MDSAP, etc.).

Nice to Have

~1 min read

Certified Quality Engineering (CQE), Certified Quality Auditor (CQA), Certified Software Quality Engineer (CSQE), Certified Reliability Engineering (CRE), Certified Biomedical Auditor (BCA), or Six Sigma Black Belt.

Consistently upholds and reflects the core ethical principles and values that bioMérieux promotes.
Written Communications – including the ability to communicate technical data in written form
Effective verbal communication skills
Critical thinking, using logic and reason to analyze information and make decisions in the workplace.
Functional skills including critical thinking, adaptability, time management, communication, problem-solving and digital literacy.
Ability to work cross-functionally allowing for better collaboration and communication when working across teams to achieve shared objectives
Skilled in MS Office tools to include but not limited to Outlook, Teams, Word, and Excel — Advanced: demonstrates deep knowledge; manages complex tasks and integrates multiple tools independently

Working Conditions and Physical Requirements (Summarized; travel shown as percentages)

Ability to remain in stationary position for prolonged periods — Yes
Ability to ascend/descend stairs, ladders, ramps — Yes
Ability to adjust or move objects up to 10 pounds — Yes
Domestic travel required: 5%
International travel required: 5%
Total travel: 10%

The estimated salary range for this role is between $92,000-$136,000 This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieux’s bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate’s experience and will be presented in writing at the time of the offer.

In addition, bioMérieux offers a competitive Total Rewards package that may include:

· A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options

· Company-Provided Life and Accidental Death Insurance

· Short and Long-Term Disability Insurance

· Retirement Plan including a generous non-discretionary employer contribution and employer match.

· Adoption Assistance

· Wellness Programs

· Employee Assistance Program

· Commuter Benefits

· Various voluntary benefit offerings

· Discount programs

· Parental leaves