Principal Quality Engineer (Wayne, NJ)

Getinge•Wayne, NJ

8d•$144,000 - $155,000•Hybrid

About The Position

The 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.

Requirements

A Bachelor’s Degree in Engineering, Science, or other related field or equivalent combination of education and related work experience is required.
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)

Nice To Haves

A Master’s of Science (or related field) or MBA is a plus.
ASQ, CQE, greenbelt or other applicable certifications are a plus.

Responsibilities

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
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
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
Identify gaps in CAPA and NC execution and drive improvements
Ensure outputs of investigations translate into process improvements, design changes, and risk management updates
Lead cross-functional problem-solving initiatives
Support internal and external audits
Ensure CAPA and NC processes are consistently executed
Contribute to inspection readiness and response activities
Mentor engineers on investigation and problem-solving approaches
Provide technical guidance across functions
Act as a key resource for difficult quality issues
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