Job OverviewThe 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 DutiesCAPA 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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