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Sr. Quality Manager, R&D

Location: Saint Louis, United States
Position Type: Unfixed Term
Job Function: Quality

A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux provides diagnostic solutions that detect disease and contamination to improve patient health and ensure consumer safety. In North America we have more than 5,000 team members across 12 sites or subsidiaries, including Salt Lake City based BioFire Diagnostics. We believe in the power of diagnostics and bioMérieux sponsors public health initiatives and partnerships to address antimicrobial resistance, sepsis awareness, food safety, and consumer health across the globe. Come be a part of our mission to help save lives.

 

The R&D Quality Manager will lead a team across R&D projects within a product portfolio generating close to one billion in revenue each year, to provide direction and expertise as subject matter experts in regard to the Product Development Process, Design Controls, and the use of harmonized standards. You are actively involved in the improvement of processes/practices and will champion new methodologies (e.g., Quality by Design, 6 Sigma) while partnering with various Functions within the organization. Lead a team of other R&D Quality professionals to guide day to day activities, prioritization, resource allocation, and drive improvements. 

 

Primary Duties:

  1. Quality representative for the Automated Microbiology Portfolio(s).  Responsible to provide coaching/mentoring to project managers, project team or Pre-Market Quality team in regard to Product Development, Design Control, Design History File, Product Risk Management throughout the product Lifecycle.  Serve as Core Team member representative for Quality.
  2. Works with design engineers and R&D to support the change management process, identifying and/or modifying risks, driving design mitigations and evaluating effectiveness of the risk control measures.
  3. Lead (or participate) global R&D process improvement initiatives and Quality Objectives.  Interface with global counterparts to drive improvement and compliance in design control.
  4. Provide input into training modules supporting Pre-Market Quality operations and deliver training.
  5. Support the complaints intake teams with assessment of risks related to reported complaints.
  6. Manage a team of R&D Quality professionals.
  7. Perform all work in compliance with company quality procedures and standards, and host or participate in regulatory or third party audits.
  8. Performs other duties as assigned.

 

Requirements and Skills:

  • Bachelor’s Degree + 2-5 years industry experience
  • Supports R&D Product Development and Lifecycle Management of the Automated Microbiology product lines, VITEK2, BacT/ALERT, VIRTUO, OBSERVA and VITEK Mass Spec.
  • Travel expectations are less than 10%.
  • Manage the department budget

 

Joining bioMérieux, is choosing to join an innovative company with a long term vision, committed to the service of public health and carried out with a humanistic corporate culture. Our Group offers numerous possibilities: so come and join the 13,000 bioMérieux team members who already identify with these values!

 

bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity/GINA.

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