Director Global PQA

About the role

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.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• 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.

Job Title

Director, Global Product Quality Assurance

The Opportunity

The Director, Global Product Quality Assurance directs and coordinates the on-market Quality Assurance activities for complaint handling, risk management, and product monitoring for Abbott Diabetes Care (ADC). Responsibilities include ensuring assigned Quality System responsibilities are completed efficiently and support outputs that improve customer satisfaction while maintaining compliance.

Responsibilities include advising senior management regarding action plans for critical events related to product quality and product safety. The position also has direct interface and activity/strategy coordination with leadership teams in Global manufacturing, Commercial, Regulatory Affairs and Legal and extends to external business partners (TPMs) and regulators.

What You’ll Work On

• Responsible for implementing and maintaining the effectiveness of the quality system.
• Develop the product quality strategy to achieve business objectives while ensuring compliance with global regulatory requirements, making key decisions on product quality issues.
• Assure line of communication with DVP Quality Assurance and Senior Leaders on critical quality issues.
• Lead the Plant & Division Product Quality Assurance organizations. Assure business continuity in leadership positions and critical roles through talent management planning and development. Create a diverse organization and encourage diversity within the organization.
• Direct and implement programs across the Division to ensure improved customer satisfaction and compliance with regulatory requirements. Monitor customer complaint trends, identifies, communicates, and addresses adverse trends that may impact the business / customer.
• Provide feedback into product improvement initiatives using customer data.
• Provide oversight to disposition high-risk product non-conformance situations, assure adequate investigation and corrective actions are in place to prevent future occurrences.
• Support cost controls of both plant Quality Operations and Division staff. Authorizes cost efficiency projects that contributes to Division margin improvement initiatives.
• Directly responsible with interface with outside regulators (FDA, Ministries of Health, Notified Bodies) and other government regulatory bodies.

Required Qualifications

• Bachelor’s degree in a scientific or technical field.
• Minimum 6 years of experience in the Medical Device industry or other FDA regulated industry.
• Experience in a role in Quality/Compliance discipline while holding positions of leadership responsibility.

Pay and benefits

The base pay for this position is $172,000.00 – $344,000.00

In specific locations, the pay range may vary from the range posted.

• JOB FAMILY: Operations Quality
• DIVISION: ADC Diabetes Care
• LOCATION: United States > Alameda: 2901 Harbor Bay Parkway

Additional Locations

• WORK SHIFT: Standard
• TRAVEL: Not specified
• MEDICAL SURVEILLANCE: Not Applicable

Significant Work Activities

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)