Postmarket Surveillance Manager

Post-Market Surveillance Manager

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 of which you dream.
• 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.

We currently have an opening for a Post-Market Surveillance Manager for the Vascular division. This role can be located at our St. Paul, MN location.

Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.

Manage a post-market surveillance team that executes the complaint investigation process for devices. Post market surveillance processes and activities are mainly related to Complaint Investigations, Medical Device / Vigilance reporting, metrics monitoring and supporting external audits/inspections.

Essential Duties and Responsibilities:

• →Manages a team of contributors on post market surveillance activities. This includes the investigation of product malfunctions, product design and/or labeling problems, as well as customer dissatisfaction issues, and the regular monitoring and reporting of complaint handling status and metrics. Monitors metrics and drives process improvements based on performance trends
• →Drive product quality improvements and support quality-based processes to ensure the highest quality of products and solutions as well as compliance with all applicable regulations and requirements
• →Collaborate with business partners to share feedback in order to improve product performance
• →Ensure proper analysis of product quality, safety, and reliability issues and effective communication to management and other functions as required. Initiate and facilitate corrective or preventative actions as needed
• →Ensure quality customer and regulatory communications for current products
• →Manage issues where analysis of situations or data requires an in-depth knowledge of organizational objectives
• →Support and participate in internal and external audits, risk management summaries, health hazard evaluations
• →Prepare and provide monthly reports to trend key quality measures as part of the corrective and preventive action (CAPA) system. Provide mentoring to Quality teams members to ensure growth
• →Working with Quality, Marketing, Product Development, Clinical and Regulatory on post market surveillance reports. Work directly with customers on issues, as needed

Required Qualifications:

• →Bachelor’s Degree in Statistics, Mathematics, Engineering, Science or other technical discipline
• →6+ years' experience in quality systems, complaint handling, regulatory reporting (or 4+ years with Master's)
• →Working knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169
• →Experience working in a regulated environment
• →Experience managing and leading a team or acting as a lead to resolve issues
• →Demonstrated critical thinking skills focused on improved system performance outcomes and positive impact
• →Excellent problem-solving skills; demonstrated application of structured problem-solving methods and tools
• →Technical writing and presentation skills.

Specifications/Other:

• →Physical abilities (must be able to lift 50 lbs.)
• →Mental abilities (Use a computer 8 hours per day)
• →Working Conditions (Regular office environment; require the ability to sit, stand and work at a desk)

Apply Now