Join our Talent Network
Skip to main content

Senior Quality Engineer-Instruments

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 which determine the source of disease and contamination to improve patient health and ensure consumer safety.
In North America we have more than 5,000 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.

Position Summary:

The Senior Instruments Quality Engineer is responsible for ensuring products and services are developed, manufactured, tested and delivered according to the established procedures. In this role, you will provide quality engineering support in the areas of deviation management, change control, internal auditing, quality trends, quality costs, training, corrective and preventive actions, process control, customer complaints, calibrations, documentation control to ensure compliance with the FDA and other regulatory requirements.

 

Primary Duties:

  1. Control and assessment of manufacturing quality. Participate in the site Internal audit and compliance review programs.
  2. Resolve and trend department deviations, ensuring compliance of all records to quality procedures. 
  3. Provide periodic trend reporting as required (QSMR, weekly and quarterly trending, monthly site metrics).
  4. Act as principal Quality contact for department risk management activities.
  5. Participate and provide guidance for Supplier change checklist process, as required.
  6. Act as a quality contact for evaluation of incoming QC and in-process materials. Ensure the disposition of non-conforming materials meet all site and regulatory requirements.
  7. Provide quality support and approval signatures for Validations, Verifications, Qualifications, and Technical Reports, as required.
  8. Review and approves First Article Inspection of components as needed.
  9. Participate in site CAPA activities, including analysis of data and trends, nonconforming material, complaints, training effectiveness, and root cause analysis.  Coordinates the implementation of corrective actions and preventive measures as needed.
  10. Provide input and approval in QC inspection methods as needed.
  11. Act as Change Review Board chair person and Quality reviewer/approver for change management activities.
  12. Review Bill of Material (BOMs), Assembly Procedures, Drawings, and Component Specification for accuracy.
  13. Monitor the manufacturing of assigned products, ensuring compliance with DMR while providing deviation/waiver guidance.  Ensures complete and correct Device History Records are maintained through DHR review and periodic audits.
  14. Participate in the development  and execution of training programs (GMP, risk analysis, statistics, etc.) as needed.  Supports continuous improvement and Global projects as needed.

 

Education and Experience:

  1. Requires a Bachelors degree in a scientific field and a minimum of 5 years related experience with competence in the selection and use of Quality Engineering Tools and Techniques.
  2. 10 years of relevant experience with be accepted in lieu of degree.
  3. Must posses effective written and verbal communication skills.
  4. Requires strong computer skills including Microsoft Office Package (Excel, Word, etc.).
  5. Must have a expert knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (ISO, QSR, UL, CSA, VDE, etc.).
  6. Certification in one of the following is highly desired:  CQE, CSQE, CRE, CQA, CBA, or Six Sigma Green Belt.

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

 

#bmx1974

 

 

 

Share: share to e-mail

Similar Jobs

Validation Engineer

Saint Louis, United States
Quality

Final QC Technical Lab Lead

Saint Louis, United States
Quality

Associate Staff Quality Engineer (Product Development)

Saint Louis, United States
Quality

RQ Compliance Analyst (Regulatory Compliance Analyst)

Saint Louis, United States
Quality

Regulatory & Compliance Specialist

Saint Louis, United States
Quality

Senior Quality Engineer-Instruments

Saint Louis, United States
Quality

Vigilance Specialist

Saint Louis, United States
Quality

Instruments Quality Engineer

Saint Louis, United States
Quality