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.
As a Senior Manager-QC Instruments, you will manage the team responsible for the Quality Control functions of Incoming Inspection of components and raw materials, In-Process audits, and the release of finished product, as appropriate. Manage the QC resources, ensuring personnel are properly trained, equipment is maintained / calibrated / validated as appropriate, inspection methods are clearly and adequately defined, and departmental documentation is current and accurate. Responsible for ensuring deviations are properly documented and investigated, nonconforming material is segregated and secured, corrective and preventive actions are effectively implemented, and supporting continuous improvement initiatives. Responsible for the management of QC-related technical issues and acts as the Quality Control liaison with Manufacturing, Supply Chain, Engineering and Quality Assurance to ensure that part-related issues are resolved as a manufacturing priority, and in a compliant manner.
- Responsible for evaluation of incoming QC and in-process materials. Ensure the disposition of non-conforming materials meet all necessary site and regulatory requirements.
- Responsible for ensuring nonconforming material is segregated and secured.
- Responsible for the inspection of components, raw materials, and finished product in accordance with specifications and ensuring release in a timely manner.
- Attends daily cross-functional production support meeting providing input on any part-related status, co-chairs meeting when required, and takes all QC action items to ensure part issues that have the potential to impact manufacturing are addressed as a priority.
- Responsible for managing a team of direct reports, ensuring personnel are properly trained and work activities are appropriately assigned to support business needs.
- Provide oversight for the execution of First Article Inspections of components by the Quality Control team.
- Responsible for ensuring that QC Inspection Methods are current and accurate.
- Participate in regulatory and agency inspections, audits, investigations, as required.
- Provide periodic trend reporting as required (QSMR, weekly and quarterly trending, monthly site metrics).
- Participate in the site Internal audit and compliance review programs.
- Act as Quality Control contact for department risk management activities.
- Interface with Manufacturing Engineering Project Leaders and R&D Product Development Leaders to ensure projects reliant on the QC Inspection function are fully supported as early in the project as possible.
- Participate and provide guidance for Supplier change checklist process, as required.
- Provide input and approval signatures for Validations, Verifications, Qualifications, and Technical Reports, as required.
- 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.
- Participate in Change Review acitivies as they pertain to Quality Control procedures and processes.
- Ensures complete and correct Device History Records are maintained through DHR review, as required.
- Provide guidance for deviations / waivers, as required
- Participate in the development and execution of training programs (GMP, risk analysis, statistics, etc.) as needed.
- Support continuous improvement and Global projects as needed.
- Share experience and provide compliance-related guidance to direct reports and supported departments.
Knowledge, Experience and Skills:
- Bachelors Degree in a Scientific field (Biology, Chemistry, Biotechnology, Engineering or similar discipline).
- 7+ years related experience in managing direct reports and competence in the use of Quality Tools and Techniques.
- 15+ years of related experience will be accepted in lieu of a degree.
- Ability to effectively communicate written and verbally.
- Requires strong computer skills including Microsoft Office Package (Excel, Word, etc.).
- 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.).
bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity/GINA.