The Opportunity

The Director, Quality Engineering will provide oversight and management for the functional areas of the Quality organization. The site Quality Director ensures that the manufacturing quality system requirements are effectively established and maintained, and reports on the performance of the quality system to management with executive responsibility for review. This position is the site-level Quality Management Representative and is responsible for ensuring site-level compliance with the established Quality System and will assure the overall quality of products and services meet internal and external customer requirements.

What You'll Work On

1. Quality Assurance Oversight : Ensuring that all quality assurance processes and systems meet regulatory standards and company policies across all sites (Manufacturing and TPM sites)

2. Regulatory Compliance : Keeping up-to-date with local and international regulations (e.g., FDA, ISO 13485) and ensuring that all sites comply with these standards.

3. Quality Management System (QMS) : Overseeing the development, implementation, maintenance and alignment of the QMS in accordance with regulatory requirements and industry best practices.

4. Risk Management : Identifying and mitigating risks associated with product quality and safety through effective risk management practices.

5. Team Leadership : Leading and mentoring a team of quality personnel across various locations, ensuring effective communication and collaboration.

6. Training and Development : Developing training programs and materials to ensure that staff at all sites are knowledgeable about quality standards and practices.

7. Audits and Inspections : Coordinating and managing internal and external audits, as well as inspections by regulatory bodies, ensuring that all findings are addressed.

8. Continuous Improvement : Promoting a culture of continuous improvement by implementing quality improvement initiatives and tools (e.g., Six Sigma, Lean methodologies).

9. Cross-Functional Collaboration : Collaborating with other departments such as R&D, Manufacturing, Regulatory Affairs, Operations and Engineering to ensure quality is integrated into all aspects of the product lifecycle.

10. Reporting and Metrics : Establishing key performance indicators (KPIs) and metrics to assess quality performance and reporting these to senior leadership.

11. Develop quality strategies to achieve business objectives across the division manufacturing plants and TPM’s globally ensuring alignment in processes / systems where possible.

12. Provide oversight to disposition of high-risk product nonconformance situation, assure adequate technical investigations and appropriate corrective actions are in place to prevent reoccurrence.

13. Responsible for leading / supporting the implementation of multi-million-dollar capital projects at the Division Manufacturing Plants and Third-Party Manufacturers globally.

14. Provide leadership and direction to Manufacturing QA & TPM teams (Technical, Operations and Engineering) to enhance and improve regulatory compliance while meeting customer requirements.

15. Act as key technical Quality interface between TPM’s and ADC internal departments including Ops, Engineering, R&D, RA, Technical and commercial.

16. Provide overall site direction and leadership for product quality and compliance.

17. Develop, implement, and improve quality processes and procedures, automated systems and reporting systems.

18. Aggressively identify opportunities to proactively assure compliance to all applicable internal, domestic, and international quality regulations, including EN ISO 13485, 21CFR 820 Quality System Regulation, MDD, JPAL and CMDR.

19. Serves as the primary site Management Representative for external regulatory inspections and audits.

20. Ensures that product acceptance activities are handles in a manner that complies with all pertinent regulatory requirements. Reports on the performance of the quality system.

21. Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Sets goals which align to department plans and manages the execution of goals through coaching and mentoring. Maintains a safe and professional work environment.

22. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Required Qualifications

• Bachelor’s degree in Engineering, Sciences, or a related field, or an equivalent combination of education and work experience
• Minimum of 10 years progressive work experience in medical device or high technology industries
• Minimum 5 years of prior management experience

Preferred Qualifications