<img alt="" src="https://www.getinge.com/siteassets/start/company/careers/Global_careers-portal90123.jpg"> 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 <ul style="margin-bottom:0.0in;margin-top:0.0px"> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Lead or support CAPA investigations, including data collection, analysis, and documentation</li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Support determination of root cause and development of corrective actions</li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Review NC and CAPA records for completeness, clarity, and alignment to the problem</li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Help ensure NCs are properly evaluated for CAPA escalation</li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Support linkage between NC trends, complaints, audit findings, and CAPA activity</li> </ul> System Performance and Metrics <ul style="margin-top:0.0in;margin-bottom:1.0 E-4pt"> <li style="margin:0.0in 20.15pt 1.0 E-4pt 0.0px;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Analyze CAPA and NC performance metrics (aging, recurrence, effectiveness)</li> <li style="margin:0.0in 20.15pt 1.0 E-4pt 0.0px;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Identify trends and support actions to address recurring issues</li> <li style="margin:0.0in 20.15pt 1.0 E-4pt 0.0px;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Support preparation of data for management review</li> </ul> Problem Solving and Investigations <ul style="margin-top:0.0in;margin-bottom:1.0 E-4pt"> <li style="margin:0.0in 20.15pt 1.0 E-4pt 0.0px;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Participate in cross-functional investigations of product and process issues</li> <li style="margin:0.0in 20.15pt 1.0 E-4pt 0.0px;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Gather and analyze data to support conclusions</li> <li style="margin:0.0in 20.15pt 1.0 E-4pt 0.0px;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Help ensure investigations are structured, fact-based, and clearly documented</li> </ul> Process and Continuous Improvement <ul style="margin-top:0.0in;margin-bottom:1.0 E-4pt"> <li style="margin:0.0in 20.15pt 1.0 E-4pt 0.0px;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Support identification of recurring or systemic quality issues across products and processes</li> <li style="margin:0.0in 20.15pt 1.0 E-4pt 0.0px;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Participate in CAPA and NC process improvements</li> <li style="margin:0.0in 20.15pt 1.0 E-4pt 0.0px;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Help ensure investigation outputs are translated into process or product improvements</li> </ul> Technical Quality Engineering Support <ul style="margin-top:0.0in;margin-bottom:1.0 E-4pt"> <li style="margin:0.0in 20.15pt 1.0 E-4pt 0.0px;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Support: <ul style="list-style-type:circle;margin-top:0.0in;margin-bottom:1.0 E-4pt"> <li style="margin:0.0in 20.15pt 1.0 E-4pt 0.0px;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Design verification and validation</li> <li style="margin:0.0in 20.15pt 1.0 E-4pt 0.0px;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Process validation and qualification</li> <li style="margin:0.0in 20.15pt 1.0 E-4pt 0.0px;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Test method validation and equipment qualification</li> </ul> </li> <li style="margin:0.0in 20.15pt 1.0 E-4pt 0.0px;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Assist in resolving product and manufacturing quality issues</li> </ul> Quality Systems and Compliance <ul style="margin-top:0.0in;margin-bottom:1.0 E-4pt"> <li style="margin:0.0in 20.15pt 1.0 E-4pt 0.0px;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Support internal and external audits and inspection readiness activities</li> <li style="margin:0.0in 20.15pt 1.0 E-4pt 0.0px;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Assist in ensuring CAPA and NC processes are followed</li> <li style="margin:0.0in 20.15pt 1.0 E-4pt 0.0px;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Support follow-up and closure of audit findings</li> </ul> Health Hazard Evaluation (HHE) <ul style="margin-top:0.0in;margin-bottom:1.0 E-4pt"> <li style="margin:0.0in 20.15pt 1.0 E-4pt 0.0px;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Support Health Hazard Evaluations by providing data and technical input</li> <li style="margin:0.0in 20.15pt 1.0 E-4pt 0.0px;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Help ensure HHE outcomes are reflected in CAPA scope and containment actions</li> </ul> Leadership and Influence <ul style="margin-top:0.0in;margin-bottom:1.0 E-4pt"> <li style="margin:0.0in 20.15pt 1.0 E-4pt 0.0px;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Provide guidance to junior engineers on investigations and documentation</li> <li style="margin:0.0in 20.15pt 1.0 E-4pt 0.0px;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Contribute to cross-functional problem-solving efforts</li> <li style="margin:0.0in 20.15pt 1.0 E-4pt 0.0px;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Act as a reliable resource for day-to-day quality issues</li> </ul> Minimum Requirements <ul style="margin-top:0.0in;margin-bottom:0.0in"> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Bachelor’s Degree in Engineering, Science, or related field (or equivalent experience)</li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Minimum of 5 years experience in quality engineering, quality systems, or related function in a regulated industry</li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Demonstrated experience with CAPA execution, nonconformance investigation and documentation, root cause analysis and corrective action development</li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Experience working in an FDA-regulated and/or ISO-certified environment</li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Working knowledge of CAPA and nonconformance systems including investigations, root cause analysis, and corrective actions</li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Ability to execute investigation, ensuring conclusions are supported by data and aligned to the problem</li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Experience supporting cross-functional problem solving for product or process issues</li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Ability to analyze quality data trends and identify recurring issues for escalation</li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Solid critical thinking and technical judgement in evaluating quality issues and root cause</li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Effective communication skills, including the ability to collaborate across functions and clearly communicate finding</li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:10.0pt;font-family:arial, helvetica, sans-serif">Working knowledge of FDA and ISO quality systems (e.g., 21 CFR 820/ QMSR, ISO 13485)</li> </ul> The base salary for this position is a minimum $115,000 of and a maximum of $125,000 plus an annual bonus of 10% #LI-LG1 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.

Sr. Quality Engineer (Wayne, NJ) (Wayne, NJ, US) @ Getinge Holding B.V. & Co. KG

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