Product Performance Manager

Abbott • St. Paul, MN

5d • $99,300 - $198,700 • Onsite

About The Position

The Product Performance Manager is responsible for leading a team that executes end-to-end complaint management processes, including complaint intake, product investigations, and post-market surveillance activities. This role partners closely with the Quality leadership team and cross-functional stakeholders to ensure a compliant and high-performing complaint handling program that supports patient safety and product quality. The role ensures compliance with global regulatory requirements and internal quality standards while driving continuous improvement in product performance management.

Requirements

• Bachelor’s degree required.
• Minimum of 5 years’ experience in the medical device industry.
• Working knowledge with applicable regulatory requirements – including ISO 13485, MDD/MDR, FDA QSR, Health Canada, ANVISA, TGA, NMPA and other international requirements as applicable.
• Experience working in a regulated environment.
• Demonstrated high levels of integrity and professionalism, with a proven ability to establish credibility and trust.
• Experience leading and managing teams or serving as a lead to drive issue resolution.
• Demonstrates critical thinking skills with a focus on improving system performance and driving positive outcomes.
• Strong problem-solving skills, with proven application of structured problem-solving methodologies and tools.
• Effective technical writing and presentation skills.
• Promotes a high-performance, diverse and inclusive culture within a quality focused environment.

Responsibilities

• Lead and manage a product performance team responsible for complaint intake, evaluation, and investigation activities.
• Oversee the complaint management process to ensure timely, accurate, and compliant handling of customer product complaints.
• Drive high-quality product investigations, including root cause analysis, corrective actions, and risk documentation.
• Ensure compliance with global regulations related to Medical Device Reporting (MDR), vigilance reporting, and other OUS applicable reporting.
• Monitor key performance metrics and drive process improvements based on trend analysis.
• Provide input and support for product performance processes, including trending, signal detection, and risk evaluation of product performance data.
• Recognize and identify potential product performance issues and drive timely escalation to the appropriate cross-functional partners to mitigate risk.
• Identify process improvement opportunities and lead initiatives to enhance efficiency, compliance, and data quality.
• Collaborate cross-functionally with Quality, Regulatory Affairs, R&D, Manufacturing, and Clinical teams to resolve product performance issues.
• Support and lead interactions with internal and external auditors, ensuring readiness and successful outcomes.
• Ensure high-quality, accurate, and compliant customer and regulatory communications.
• Ensure proper training, development, and performance management of team members.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager