Job OverviewThe Principal Quality Engineer provides technical leadership across quality engineering, manufacturing support, and design activities, with accountability for ensuring the effectiveness of Nonconformance (NC) and CAPA processes across the organization. This role leads complex investigations, drives systemic problem solving, and strengthens overall quality performance.
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 oversee complex, high-risk, or recurring CAPA investigations
- Ensure root cause and corrective actions are technically sound and appropriately scoped
- Review and challenge CAPA and NC records to drive consistency and quality of execution
- Ensure alignment between NC trends, complaints, audit findings, and CAPA activity
System Performance and Metrics- Analyze CAPA and NC performance metrics (aging, recurrence, effectiveness)
- Identify patterns and drive actions to address systemic issues
- Support management review with data-driven insights and recommended actions
- Drive identification and elimination of recurring or systemic quality issues across products and processes
Technical Quality Engineering Support- Provide support for:
- Design verification and validation
- Process validation and qualification
- Test method validation and equipment qualification
- Lead resolution of complex product and process quality issues
- Drive recovery of high-risk or overdue issues
Process and System Improvement- Identify gaps in CAPA and NC execution and drive improvements
- Ensure outputs of investigations translate into:
- Process improvements
- Design changes
- Risk management updates
- Lead cross-functional problem-solving initiatives
Quality Systems and Compliance- Support internal and external audits
- Ensure CAPA and NC processes are consistently executed
- Contribute to inspection readiness and response activities
Leadership and Influence- Mentor engineers on investigation and problem-solving approaches
- Provide technical guidance across functions
- Act as a key resource for difficult quality issues
Health Hazard Evaluation (HHE)- Lead or provide technical input to Health Hazard Evaluations for significant product or field issues
- Assess risk using available data and engineering judgment
- Ensure HHE conclusions drive CAPA scope, urgency, and actions
Required Knowledge, Skills and Abilities- A Bachelor's Degree in Engineering, Science, or other related field or equivalent combination of education and related work experience is required.
- A Master's of Science (or related field) or MBA is a plus. ASQ, CQE, greenbelt or other applicable certifications are a plus.
- A minimum of 7 years of experience in quality assurance, quality compliance, or related functions in an FDA regulated industry or ISO certified organization is required.
- Strong experience with CAPA, nonconformance systems, and complex investigations
- Strong knowledge of CAPA and nonconformance systems, including investigations, root cause analysis, and corrective actions
- Ability to assess investigation quality, ensuring conclusions are data-driven and aligned to the problem
- Experience leading cross-functional investigations or problem-solving for complex or recurring quality issues
- Demonstrated ability to identify systemic issues from recurring data and drive sustainable solutions
- Strong technical judgement and critical thinking, especially for risk and issue scope
- Effective communication skills, including the ability to challenge and influence across functions
- Working knowledge of FDA and ISO quality systems (e.g., 21CFR820/QMSR, ISO 13485)
The base salary for the position is a minimum of $144,000 and a maximum of $155,000 plus an annual bonus of 15%
#LI-LG1
