Director, Quality Engineering

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

·      Career development with an international company where you can grow the career you dream of.

·      Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

·      An excellent retirement savings plan with high employer contribution

·      Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

·      A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

·      A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

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 Th