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Sr Technical Quality Engineer

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.

Position Summary:

The Senior Technical Quality Engineer is responsible for managing processes and leading projects to maintain and improve the quality system in accordance with applicable regulatory standards.  In this role, you will ensure products and services are developed, manufactured, tested and delivered according to the established procedures.  You will provide quality engineering support in the areas of project engineering, deviation management, change control, internal auditing, quality trending, continuous improvement, training, corrective and preventive actions, process control, calibrations, and documentation control while performing all duties using safety conscious practices.

 

Primary Duties:

  1. Provide quality engineering support to manufacturing, maintenance, calibration, facilities, and project engineering departments.
  2. Conduct root cause analysis, leads process corrective actions and other problem-solving activities.
  3. Develop and implement statistically valid design of experiments (DoE), capability studies, SPC and trend analysis in support of products and service improvements
  4. Provide periodic trend reporting as required (QSMR, Continuous Process Verification).
  5. Conduct risk assessments, reviews/revises existing risk assessments through process feedback, and acts as quality representative for risk management activities
  6. Use data to perform statistical analysis and recommend process / product changes to improve product quality
  7. 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.
  8. Provide quality support and approval signatures for Validations, Qualifications, Engineering/Scientific Studies and Technical Assessments as required.
  9. Perform periodic reviews on equipment and processes as needed
  10. Review and approve calibration exception investigations, change controls, and first article inspections
  11. Participate in regulatory and agency inspections, audits, and investigations. Also participates in the site Internal audit and compliance review programs.
  12. 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.
  13. Review Bill of Material (BOMs), Assembly Procedures, Standard Operating Procedures, Drawings, and Component Specifications.
  14. Support continuous improvement projects as needed.

 

Education and Experience:

  1. BS in scientific or engineering field and a minimum of 5 years’ experience or a MS in a scientific or engineering field with a minimum of 3 years’ experience.
  2. 10 years of experience will be accepted in lieu of degree.

 

Knowledge, Skills and Abilities:

  1. Medical device or other FDA regulated industry experience preferred
  2. Must possess effective written and verbal communication skills.
  3. Requires strong computer skills including Microsoft Office Package (Excel, Word, etc.).
  4. Must have a working knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (MDSAP, 21CFR820, ISO 13485, QSR, etc.).
  5. ASQ Certification in one of the following is preferred:  CQE, CSQE, CRE, CQA, CBA, or Six Sigma Green Belt.

 

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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