Sr. Quality Engineer (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 supports quality engineering, manufacturing, and quality systems activities, with strong involvement in Nonconformance (NC) and CAPA processes. This role focuses on executing investigations, supporting problem solving, and helping ensure consistent, effective CAPA and NC practices.

The position is part of the Acute Care Therapies, Cardiac Surgery Business Area. This is a hybrid role with 4 days a week onsite in Wayne, NJ. 

 

Job Responsibilities and Essential Duties

CAPA and Nonconformance Leadership

• Lead or support CAPA investigations, including data collection, analysis, and documentation
• Support determination of root cause and development of corrective actions
• Review NC and CAPA records for completeness, clarity, and alignment to the problem
• Help ensure NCs are properly evaluated for CAPA escalation
• Support linkage between NC trends, complaints, audit findings, and CAPA activity

 

System Performance and Metrics

• Analyze CAPA and NC performance metrics (aging, recurrence, effectiveness)
• Identify trends and support actions to address recurring issues
• Support preparation of data for management review

 

Problem Solving and Investigations

• Participate in cross-functional investigations of product and process issues
• Gather and analyze data to support conclusions
• Help ensure investigations are structured, fact-based, and clearly documented

 

Process and Continuous Improvement

• Support identification of recurring or systemic quality issues across products and processes
• Participate in CAPA and NC process improvements
• Help ensure investigation outputs are translated into process or product improvements

 

Technical Quality Engineering Support

• Support:
  • Design verification and validation
  • Process validation and qualification
  • Test method validation and equipment qualification
• Assist in resolving product and manufacturing quality issues

 

Quality Systems and Compliance

• Support internal and external audits and inspection readiness activities
• Assist in ensuring CAPA and NC processes are followed
• Support follow-up and closure of audit findings

 

Health Hazard Evaluation (HHE)

• Support Health Hazard Evaluations by providing data and technical input
• Help ensure HHE outcomes are reflected in CAPA scope and containment actions

 

Leadership and Influence

• Provide guidance to junior engineers on investigations and documentation
• Contribute to cross-functional problem-solving efforts
• Act as a reliable resource for day-to-day quality issues

 

Minimum Requirements

 

• Bachelor’s Degree in Engineering, Science, or related field (or equivalent experience)
• Minimum of 5 years experience in quality engineering, quality systems, or related function in a regulated industry
• Demonstrated experience with CAPA execution, nonconformance investigation and documentation, root cause analysis and corrective action development
• Experience working in an FDA-regulated and/or ISO-certified environment
• Working knowledge of CAPA and nonconformance systems including investigations, root cause analysis, and corrective actions