Job TitlePost-Market Surveillance Manager
The OpportunityWe 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.
What You'll Do: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 NowLearn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.
The base pay for this position is $99,300.00 - $198,700.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Operations Quality
DIVISION:AVD Vascular
LOCATION:United States > Minnesota > St. Paul : 1225 Old Highway 8 NW
ADDITIONAL LOCATIONS:WORK SHIFT:Standard
TRAVEL:Yes, 10 % of the Time
MEDICAL SURVEILLANCE:No
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
