Sr. Quality Engineer (Wayne, NJ)
Getinge•Wayne, NJ
•$115,000 - $125,000•Hybrid
About The Position
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.
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)
Responsibilities
- 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
- 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
- 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
- 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
- Support design verification and validation
- Support process validation and qualification
- Support test method validation and equipment qualification
- Assist in resolving product and manufacturing quality issues
- 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
- Support Health Hazard Evaluations by providing data and technical input
- Help ensure HHE outcomes are reflected in CAPA scope and containment actions
- 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
Benefits
- annual bonus of 10%
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What This Job Offers
Job Type
Full-time
Career Level
Senior
