Senior Quality Engineer Post Market Surveillance (Wayne, NJ)

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 FDA 21 CFR Part 803, ISO 13485, ISO 14971, EU MDR (Annex III), and MEDDEV 2.12/1.
• Proven ability to prepare and lead development of PSURs, PMSRs, and inputs to CERs with cross-functional collaboration.
• Working knowledge of databases and templates used in PMS documentation.
• Strong understanding of complaint handling, signal detection, risk management, and field corrective action processes.
• Familiarity in structured problem-solving tools (e.g., 5 Whys, Fishbone/Ishikawa, Fault Tree Analysis, A3) and CAPA systems.
• Proficiency in complaint trending and statistical analysis using Excel, Minitab, or other quality tools.
• Ability to generate visual reports/dashboards and interpret data to support decision-making.
• Ability to collaborate cross-functionally with Regulatory, Clinical, Manufacturing, and Medical Affairs teams.
• Strong verbal and written communication skills, including preparation of regulatory submissions and audit responses.
• Ability to influence and Collaborate with cross-functional (Regulatory, Clinical, Manufacturing, and Medical Affairs) teams and effectively communicate technical content to regulatory authorities and internal leadership.
• Ability to mentor or coach junior engineers or team members in PMS activities is a plus.
• Preferred to be Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or Regulatory Affairs Certification (RAC).
• Deep knowledge of global post-market regulatory frameworks, including FDA 21 CFR Part 803, ISO 13485, ISO 14971, and EU MDR Annex III for PMS/PMCF.
• Familiarity with international vigilance reporting standards (e.g., FDA MDR, EU MIR, Health Canada, and other global authority expectations).
• Proven ability to lead end-to-end PMS processes, including signal detection, trend analysis, risk escalation, and cross-functional risk-benefit reviews.
• Experience generating and owning regulatory deliverables such as PSURs, PMSRs, HHE justifications, and contributions to Clinical Evaluation Reports (CERs).
• Proficient in complaint handling, product investigations, signal detection, and trend analysis.
• Skilled in applying risk management principles throughout the product lifecycle, including updating Risk Management Files (RMFs) based on post-market feedback.
• Strong analytical skills with the ability to interpret large sets of complaint and quality data to identify trends and generate actionable insights.
• Experience with tools such as Excel, Minitab, Tableau, or similar for visualizing and communicating trends.
• Hands-on experience with electronic QMS and complaint handling systems (e.g., TrackWise, Windchill).
• Excellent verbal and written communication skills, especially for preparing regulatory submissions and audit responses.
• Demonstrated ability to work cross-functionally with Regulatory Affairs, Clinical, R&D, Manufacturing, and Commercial teams.
• Confidence in representing PMS processes and data during internal audits, FDA inspections, and Notified Body reviews.
• Ability to translate complex post-market data into clear, concise justifications and regulatory narratives.
• Proactive, detail-oriented, and committed to identifying system gaps and driving improvements in PMS processes and documentation.
• Regular interaction with internal stakeholders across all levels and functions, including R&D, Regulatory Affairs, Operations, Medical Affairs, and Supplier Quality.
• May engage externally with auditors, and regulatory authorities as a representative of the Quality function.

The base salary for this position is a minimum of $100,000 and a maximum of $120,000 plus  10% annual bonus

About us 

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.  

Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.