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.
Support lifecycle management for IVD medical device products and manufacturing processes. Accountable for assuring that products are supported during its lifecycle in compliance with Design Control and applicable regulations. Participate to the continuous improvement of the Product Life Cycle processes.
- Participate in the assigned portfolio of products providing guidance and expertise on design controls for product support activities. Provide risk management guidance for manufacturing related to changes, nonconformities, complaint investigations and other issues as applicable.
- Provide coaching to site staff as needed to ensure compliance to applicable regulations. Support process harmonization across sites where practical.
- Ensures the compliance and update of DHF documents including risk management files all along the product/system life cycle.
- Accountable for key decisions affecting the quality of product (anomalies, non-conformities, Complaints).
- Ensure there are relevant justifications for any conclusions on performances, safety, statements on deviation (auditability, statistical / scientific rationale).
- Contribute to CAPA, to root cause analysis, and subsequent critical decision taken (FCA or FSCA), and other Quality Systems as necessary.
- Contribute to the reporting of Post-Market Surveillance for supported products with special focus on confirmation of risk acceptance.
- Implements Quality Engineering functional excellence (methods and tools) during product life cycle improving the quality and robustness of products partnering with Process Office.
- Develop working relationships with key business partners across the company.
Studies and Experience:
- Bachelor's degree required
- Degree in microbiology preferred
- Minimum 5 years of experience in medical devices, in vitro diagnostics, pharmaceuticals, biotechnology or microbiology is required
- Direct ISO 14971 Risk Management experience preferred.
Skills and Qualifications:
- Requires working knowledge of selection and use of Quality Engineering tools, statistical analysis techniques, data trending or manufacturing process.
- Requires knowledge of the interpretation and application of relevant Domestic and International Medical Device Regulations and Industry Standards (e.g. ISO 13485, QSR-21 CFR, IVDR, MDSAP, etc.).
- One of the following certifications is desired for this role: Certified Quality Engineering (CQE), Certified Quality Auditor (CQA), Certified Software Quality Engineer (CSQE), Certified Reliability Engineering (CRE), Certified Biomedical Auditor (BCA), or Six Sigma Black Belt.
- Requires effective written and oral communication skills to interact across all levels of the organization.
- Must possess high level of attention to detail, highly motivated and organized.
- Must have experience in and knowledge of Microsoft Office Package (Word, Excel, etc.).
- Experience and/or education in Microbiology is preferred.
- Excellent personal hygiene required in production and laboratory areas.
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).