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.
Responsible for the implementation and maintenance of effective Design Controls in accordance with FDA Quality Systems Regulation, ISO 9001, ISO 13485, and other applicable country specific regulations. Participates on quality improvement teams for quality assurance, compliance, and continuous improvement. Ensure products and services are developed and tested according to established procedures that will assure they meet quality requirements.
- Participate in activities such as; auditing, compiling quality trend information, training, validation, design controls, purchasing controls, corrective and preventive actions, process control, customer complaints, calibration, documentation control, etc. to ensure compliance with FDA, and regulatory requirements.
- Support regulatory and agency inspections, audits, investigations, and inquiries regarding manufacturing quality
- Monitor manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained
- Review the adequacy and correctness of changes to Bill of Materials (BOM’s), Assembly Procedures, Drawings, Component Specification, etc.
- Ensure that the disposition non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent reoccurrence.
- Execute Internal/Supplier Audits as needed.
- Participate in plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis. Coordinates implementation of corrective actions and preventive measures.
- Support continuous improvement projects.
- Participate in and promotes Quality on the Floor program.
- Develop and execute training programs (e.g. change control, GMP, risk analysis, statistics, etc.)
Studies, Experience, Skills and Qualifications:
- Bachelor's Degree Required.
- Requires a minimum of eight (8) years experience in a related industry regulated by FDA and/or ISO.
- Requires demonstrated competence in the selection and use of Quality Engineering tools, techniques, and processes.
- Must possess knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, IVDR, MDSAP, etc.).
- One of the following certifications is desired for this role, but not required: Certified Quality Engineering (CQE), Certified Quality Auditor (CQA), Certified Software Quality Engineer (CSQE), Certified Reliability Engineering (CRE), Certified Biomedical Auditor (CBA), or Six Sigma Black Belt.
- Requires effective written and oral communication skills to interact across all levels of the organzation.
- Must have experience in and knowledge of Microsoft Office Package (Word, Excel, etc.).
- Excellent personal hygiene required in production and laboratory areas.
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.