Postmarket Surveillance Manager

Responsibilities

• Manage a post-market surveillance team responsible for complaint investigations, medical device vigilance reporting, and metrics monitoring
• Drive product quality improvements and ensure compliance with all applicable global regulations and requirements
• Collaborate with business partners to share feedback and improve product performance
• Ensure proper analysis of product quality, safety, and reliability issues, initiating corrective or preventative actions (CAPA) as needed
• Support and participate in internal and external audits, risk management summaries, and health hazard evaluations
• Prepare monthly reports to trend key quality measures and provide mentoring to Quality team members

Requirements

• Bachelor’s Degree in Statistics, Mathematics, Engineering, Science, or another technical discipline
• 6+ years of experience in quality systems, complaint handling, or regulatory reporting (or 4+ years with a Master's degree)
• Working knowledge of global medical device regulations including 21 CFR Parts 803, 806, and 820, as well as ISO13485 and ISO14971
• Proven experience managing and leading a team or acting as a lead to resolve complex issues
• Strong technical writing and presentation skills
• Demonstrated critical thinking and structured problem-solving skills in a regulated environment

Benefits

• Career development opportunities within an international healthcare leader
• Access to medical coverage through the Health Investment Plan (HIP) PPO plan
• Excellent retirement savings plan with high employer contributions
• Tuition reimbursement and specialized student debt and education programs
• A diverse and inclusive work environment recognized as a great place to work globally

About the Company

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. With over 115,000 colleagues, we serve people in more than 160 countries.