🌎
This job posting isn't available in all website languages

Post Market Surveillance Manager

📁
Quality
📅
21000BAO Requisition #

Position Description:
Post Market Surveillance Manager, Covidien LP (a Medtronic company), Irvine, CA. The Post Market Surveillance Manager located at the Irvine, CA location has responsibility and authority related to complaint handling, complaint analysis and adverse experience reporting activities for Neurovascular products and systems. Collaborate to improve and adhere to Restorative Therapies Group Customer Quality standards. Have overall responsibility to ensure complaint handling and vigilance are optimized and executed appropriately to meet the changing needs of the global regulatory requirements. Responsible for all complaint analysis activities, Medical Device Reporting (MDR) and complaint handling to include FDA adverse event reporting requirements. Utilize problem solving tool using Define, Measure, Analyze, Improve and Control (DMAIC) methodology. Navigate the complexities of various Medical Device Regulations to include FDA QSR 21 CFR part 820, 803 & 806, EU Medical Device Regulations, ISO-13485, ISO-14971 and ISO 9001. Utilize Lean Manufacturing and Six Sigma methodologies. Coordinate CAPA (Corrective and Preventive Action) planning and implementation. Responsible for various Risk Deliverables including Use, Design and Process Failure Mode Effects Analysis (U/D/PFMEA) and Product Hazard Analysis. Responsible for Complaint and Product Failure Investigations and pre and post market root cause analysis along with responses to regulatory inquiries. 

Basic Qualifications:
Master’s degree in Nursing, Biology or Biomedical Engineering and 3 years of experience in Medical Device Reporting compliance. Must possess a minimum of 3 years of experience with each of the following: Complaint analysis activities, Medical Device Reporting (MDR) and complaint handling to include FDA adverse event reporting requirements; DMAIC methodology; FDA QSR 21 CFR part 820, 803 & 806, ISO-13485, ISO-14971 and ISO 9001; Lean manufacturing and Six Sigma methodologies; CAPA (Corrective and Preventive Action) planning and implementation; Use, Design and Process Failure Mode Effects Analysis (U/D/PFMEA) and Product Hazard Analysis; and Complaint and Product Failure Investigations and pre and post market root cause analysis, and responses to regulatory inquiries.

My Profile

Create and manage profiles for future opportunities.

Go to Profile

My Submissions

Track your opportunities.

My Submissions

Similar Listings

Irvine, California, United States

📁 Quality

Requisition #: 210008LM

Irvine, California, United States

📁 Quality

Requisition #: 2100033C

Irvine, California, United States

📁 Quality

Requisition #: 21000CGT

FORTUNE NAMES MEDTRONIC TO 'CHANGE THE WORLD' LIST

FORTUNE puts Medtronic among the top 20 companies worldwide having a positive social impact through core business strategy.

Read The Story

ENGINEERING

Bring your talents to help us build life-changing technology

LEARN MORE

Three Women Working

INCLUSION AND DIVERSITY

We believe that when people from different cultures, genders, and points of view come together, innovation is the result — and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.

SEE HOW