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Sr Quality Engineer

Location: Hazelwood, MO, United States
Position Type: Unfixed Term
Job Function: Quality

A world leader in the field of in vitro diagnostics for more than 60 years, bioMérieux provides diagnostic solutions which determine the source of disease and contamination to improve patient health and ensure consumer safety.

In North America we have more than 6,200 team members across 11 sites or subsidiaries, including Salt Lake City-based BioFire Diagnostics and one subsidiary in Montreal, Canada.

Come and join a family-owned global company with a long-term vision, and a human-centered culture.

Description

Position Summary & Responsibilities:

Support quality programs to develop, implement, and continually improve systems to ensure customer requirements are implemented into the Company products and services.  Support operations compliance with government regulations (FDA, Canadian Medical Device Registration, IVD Directive and other applicable regulations) and all other applicable standards (ISO, etc.).  Lead Change Control efforts for Product Labeling.

  • Perform analysis for Drug Component Specification revisions impacting VITEK 2 AST Product Labeling.
  • Track VITEK 2 AST Product Labeling modifications and coordinate with Product Labeling & Documentation to prepare for implementation.
  • Initiate and process change requests related to the life cycle management of VITEK 2 AST and Identification Product Labeling Deliverables.
  • Lead and support assessments of the quality systems for compliance (e.g. customers, FDA, ISO Registrars), and ensure that such assessments are conducted in accordance with established policies and procedures to maximize their benefit.
  • Participate in teams to accomplish deliverables, milestones, and objectives to meet plans and schedules by ensuring that any changes to the plans are communicated and agreed to by teams and project sponsors for the St. Louis site.  This includes standardizing processes at the site to ensure the North America ISO 9001 & 13485 and MDSAP registration is maintained.
  • Participate in the Corrective and Preventive Action programs to lead process, product and service improvements related to the Quality System.
  • Support the site by ensuring relevant documentation meets the requirements of 21CFRPart 820 Quality System Regulation, In-Vitro Diagnostic Directive and other country specific regulatory requirements.
  • Participate in site or external auditing processes as necessary
  • Manage site compliance projects as needed
  • Lead, author, and/or facilitate root cause investigations.

Education, Skills, & Experience:

  • Bachelor's degree in a scientific field with 3+ years of experience in Quality Engineering, Quality Control, or Quality Systems required.
    • Master's degree with 1+ year of experience in Quality Engineering, Quality Control, or Quality Systems required also accepted
    • Requires 1+ year progressively responsible quality systems experience in a relevant industry (such as medical device). 
  • Requires strong computer skills including Microsoft Office Package (Excel, Word, etc.). 
  • Must have expert knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (ISO, QSR, UL, CSA, VDE, etc.). 
  • Must possess strong interpersonal, written and oral communication skills.
  • Certification in one of the following is preferred:  CQE, CQA, CBA, CMQ/OE, or Six Sigma Black Belt.

#LI-US

Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMérieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https://careers.biomerieux.com/ or contact us at [email protected].

BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

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