Senior Quality Engineer Post Market Surveillance

 

 

With a passion for life

 

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

 

 

Job Overview

The Senior Quality Engineer, Post Market Surveillance, leads and executes global post-market surveillance (PMS) and post-market clinical follow-up (PMCF) activities for Class II/III medical devices across the product lifecycle. This role owns the processes for complaint trending, signal detection, nonconformance escalation, and vigilance reporting to ensure regulatory compliance and continuous improvement. The incumbent acts as a Subject Matter Expert (SME) for PMS, interfacing with regulatory authorities and leading regulatory and notified body audits. They contribute to strategic quality initiatives by developing Periodic Safety Update Reports (PSURs), supporting Clinical Evaluation Reports (CERs), and driving risk-benefit assessments, field actions, and CAPA resolution. This role requires strong cross-functional collaboration and the ability to translate complex quality data into meaningful regulatory, clinical, and product performance insights. The position supports both the Cardiac Assist (CA) and Cardiac Surgery (CS).

The position is hybrid with a minimum of 2 days a week onsite in Wayne, NJ.

 

Job Responsibilities and Essential Duties

• Lead global post-market surveillance activities including complaint handling, vigilance reporting, and trend analysis in compliance with FDA 21 CFR 803, EU MDR, ISO 13485, and other applicable regulations.
• Perform proactive analysis of complaint, nonconformance, and manufacturing data to identify emerging quality signals; escalate findings and initiate CAPAs or risk mitigations as appropriate.
• Own the development and submission of Periodic Safety Update Reports (PSURs) and Post-Market Surveillance Reports (PMSRs), consolidating product safety, complaint, and performance data.
• Provide strategic inputs and post-market data for Clinical Evaluation Reports (CERs), including benefit-risk updates, complaint summaries, and safety conclusions.
• Lead cross-functional investigations for post-market safety signals, adverse events, and field performance issues using structured root cause analysis tools (e.g., 5 Whys, Fishbone, FTA).
• Support and lead Health Hazard Evaluations (HHEs), field action decision-making, and recall execution activities.
• Monitor and interpret manufacturing-related triggers and nonconformance trends to anticipate field risk; integrate findings into PMS documentation and quality improvement plans.
• Ensure maintenance and accuracy of complaint and nonconformance databases; align data categorization and risk logic with Risk Management Files (RMF) per ISO 14971.
• Represent PMS as a Subject Matter Expert during internal and external audits (FDA, Notified Body, MDSAP), including preparation and defense of complaint and surveillance data.
• Lead CAPA activities arising from post-market insights, ensuring effective root cause analysis, corrective action implementation, and timely closure.
• Collaborate with cross-functional teams (Regulatory, Clinical, R&D, Manufacturing, Medical Affairs, and Commercial) to align on product safety and surveillance strategies.
• Identify and drive continuous improvement initiatives in PMS processes, procedures, and system tools; contribute to updates of SOPs, templates, and quality system documentation.
• Support quality input into design changes, supplier quality assessments, and validations based on post-market feedback.
• Work special projects as assigned.

 

Required Knowledge, Skills, and Abilities

• Bachelor’s degree in Engineering, Life Sciences, Biomedical Engineering, or a related technical discipline is required. 
• Minimum 5 years of experience in Quality Assurance, Post-Market Surveillance, or Regulatory Affairs within the medical device industry.
• Demonstrated experience leading complaint handling, vigilance reporting, signal detection, and PMS documentation for Class II/III medical devices.
• Prior experienced preferred in participation of FDA inspections, Notified Body audits, or MDSAP assessments as a Quality or PMS subject matter expert.
• Strong working knowledge of U.S. and international medical device regulations, including