Principal Quality Engineer (Medtech)

TL;DR

Principal Quality Engineer (Medtech): Providing technical leadership across quality engineering and manufacturing support with an accent on CAPA and Nonconformance processes. Focus on leading complex investigations, driving systemic problem solving, and ensuring strict compliance with FDA and ISO standards.

Location: Hybrid: 4 days a week onsite in Wayne, NJ

Salary: $144,000 – $155,000 plus annual bonus targeted at 15%

Company

hirify.global provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows across intensive care, cardiovascular procedures, and operating rooms.

What you will do

• Lead and oversee complex, high-risk, or recurring CAPA investigations and ensure corrective actions are technically sound.
• Analyze CAPA and NC performance metrics to identify patterns and eliminate systemic quality issues.
• Support design verification, process validation, and test method qualification.
• Mentor engineers on investigation and problem-solving approaches and provide technical guidance across functions.
• Lead Health Hazard Evaluations (HHE) for significant product or field issues to determine urgency and scope.
• Ensure quality systems compliance and contribute to internal and external audit inspection readiness.

Requirements

• Bachelor’s Degree in Engineering, Science, or a related field.
• Minimum 7 years of experience in quality assurance or compliance within an FDA regulated industry or ISO certified organization.
• Strong expertise in CAPA, nonconformance systems, and root cause analysis.
• Working knowledge of FDA and ISO quality systems (e.g., 21CFR820/QMSR, ISO 13485).
• Ability to lead cross-functional investigations and influence stakeholders across the organization.

Nice to have

• Master’s of Science or MBA.
• ASQ, CQE, Greenbelt, or other applicable quality certifications.

Culture & Benefits

• Collaborative environment with diverse teams of passionate people.
• Career path supporting both personal and professional development.
• Annual bonus targeting 15% of base salary.
• Opportunity to work on life-saving technology making a real difference for customers.