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. bioMérieux's global headquarters is located in Marcy L'Étoile, France, and we have more than 11,200 team members in 43 countries. With our distributor network, we serve more than 160 countries. bioMérieux, Inc., our Americas division, has more than 4,000 team members across 12 sites or subsidiaries. Our Americas headquarters is in Durham, NC, with nearly 1,200 team members. bioMérieux, Inc. sponsors public health initiatives and partnerships to address antimicrobial resistance, sepsis awareness, food safety, and consumer health. Our passionate team members recognize the power of diagnostics and rally behind our mission to help save lives.
Ensures products and services are developed, manufactured, tested and delivered according to the established procedures. Provides 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. Performs all duties using safety conscious practices.
Participates in regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of manufacturing quality.
Resolve, and trend department deviations, ensuring compliance of all records to quality procedures.
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 contact for department risk management activities.
Participate and provide guidance for Supplier change checklist process, as required.
Acts as a quality contact for evaluation of incoming QC and in-process materials. Ensure the disposition of non-conforming materials meet all necessary site and regulatory requirements.
Provide quality support and approval signatures for Validations, Verifications, Qualifications, and Technical Reports, as required.
Review and approves First Article Inspection of components as needed.
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.
Provide input and approval in QC inspection methods as needed.
Act as Change Review Board chair person and Quality reviewer/approver for change management activities.
Review Bill of Material (BOMs), Assembly Procedures, Drawings, and Component Specification for accuracy.
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.
Participates in the development and execution of training programs (GMP, risk analysis, statistics, etc.) as needed.
Support continuous improvement and Global projects as needed.
Studies/Experience, Skills and Qualifications:
Requires a Bachelors degree in a scientific field.
Requires a minimum of 3 years related experience with competence in the selection and use of Quality Engineering Tools and Techniques.
Ability to effectively communicate written and verbally.
Requires strong computer skills including Microsoft Office Package (Excel, Word, etc.).
Must have a knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (ISO, QSR, UL, CSA, VDE, etc.).
Certification in one of the following is desired: CQE, CSQE, CRE, CQA, CBA, or Six Sigma Green Belt.
Must be able to lift 5-10lbs.
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 11,200 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