Director Global PQA

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.