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 Ability to execute investigation, ensuring conclusions are supported by data and aligned to the problem Experience supporting cross-functional problem solving for product or process issues Ability to analyze quality data trends and identify recurring issues for escalation Solid critical thinking and technical judgement in evaluating quality issues and root cause Effective communication skills, including the ability to collaborate across functions and clearly communicate finding Working knowledge of FDA and ISO quality systems (e.g., 21 CFR 820/ QMSR, ISO 13485)

The base salary for this position is a minimum $115,000 of and a maximum of $125,000 plus an annual bonus of 10%

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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.