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Associate Director, QA/QC

Location: Saint Louis, United States
Position Type: Unfixed Term
Job Function: Quality

A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 44 countries and serve 160 countries with the support of a large distribution network. This includes our SLC site, formerly known as BioFire Diagnostics.

 

 

Position Summary

Ensure products (and services) are developed, manufactured, tested, and delivered in accordance with established procedures that will assure they meet all quality requirements.  Responsible to lead the efforts to continuously improve the manufacturing of products and services provided in accordance with government regulations (FDA-Quality System Regulation, Canadian-Medical Device Registration, IVD Directive and other applicable country specific regulations) and applicable standards (ISO-9001: 2000 & ISO 13485, etc.), and enhance stakeholder value.  Develop, implement, and monitor the performance of Quality Control processes, metrics, personnel, and testing methods to ensure reagents conformance.  Monitor Quality Assurance metrics, provide manufacturing floor quality support, and determine disposition of material.  Provide coaching, feedback, guidance, and training to employees, ensuring and engaged and skilled staff.

 

Primary Duties

1. Design and maintain Quality programs for Reagent QA and QC functions to facilitate continuous improvement actions

2. Develop and maintain quality performance metrics to provide management a method of assessing the effectiveness of production processes, current specifications, test methods, and personnel performance.

3. Ensure Nonconforming Material systems are effectively implemented and maintained

4. Oversee microbiological and analytical chemistry functions, as well as material testing functions, ensuring efficiency to meet production demands and continuous improvement of departmental performance. Ensure timeliness and efficiency of goods and material testing.

5. Develop and implement site and departmental operational procedures to ensure regulatory and organizational compliance (FDA, GMP, ISO, CLIA, OSHA, etc.).

6. Lead efforts for improving quality & productivity performance for the Reagents team, offer troubleshooting expertise, and conduct quality improvement studies where appropriate in other areas.

7. Lead efforts to ensure continuous product and process improvement in areas of responsibility.

8. Responsible for developing and maintaining regular Quality Control/Assurance trend data and reports. Develop and maintain annual departmental budget plans.

9. Support Reagent manufacturing through management of the environmental monitoring program. Supports ongoing product stability testing.

10. Works with other departments to ensure operational and quality goals are understood and met.

11. Provide methods to communicate the quality status of materials and processes to internal customers, management, and external suppliers.

12. Contribute to Supplier Quality defined goals

13. Support review of customer complaints. Participate as needed on special teams and/or projects.

14. Monitor and maintain departmental personnel meet commitments / deadlines. Lead team members by establishing performance criteria, providing training and resources, giving regular coaching, feedback and guidance. Ensures an engaged and skilled workforce through active listening and communication.

 

Knowledge, Experience, and Skills

 

  1. Must have a strong knowledge of GMP, ISO, and FDA compliance. Requires Bachelors Degree with twelve (10) years industry experience in a related industry. 
  2. Must have experience and demonstrated ability to lead teams.  Five (5)+ years experience managing large groups is highly preferred.
  3. Must have excellent interpersonal skills, with the ability to effectively communicate written and orally.
  4. Experience in directly managing regulatory audits by FDA and ISO.  Competence in the selection and use of Quality Engineering Tools and Techniques. 
  5. Expert knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, CSA, VDE, etc.)
  6. Certified Quality Engineering (CQE), Certified Quality Auditor (CQA), CBA (Certified Biomedical Auditor), CMQ/OE (Certified Manager of Quality / Operational Excellence) or Six Sigma Black Belt desired.

 

bioMérieux welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

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).

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