Senior Quality Engineer (Medtech)

TL;DR

Senior Quality Engineer (Medtech): Supporting quality engineering and manufacturing systems with an accent on Nonconformance (NC) and CAPA processes. Focus on executing investigations, performing root cause analysis, and ensuring compliance with FDA and ISO standards.

Location: Hybrid (4 days onsite in Wayne, NJ)

Salary: $115,000 – $125,000 plus 10% annual bonus

Company

hirify.global provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows.

What you will do

• Lead and support CAPA investigations, including data collection, analysis, and documentation.
• Review NC and CAPA records for completeness, clarity, and alignment to the problem.
• Analyze CAPA and NC performance metrics to identify trends and address recurring issues.
• Participate in cross-functional investigations of product and process issues.
• Support design verification, process validation, and equipment qualification.
• Ensure inspection readiness and support internal and external audits.

Requirements

• Bachelor’s Degree in Engineering, Science, or a related field.
• Minimum of 5 years experience in quality engineering or quality systems in a regulated industry.
• Must be based in or able to work onsite in Wayne, NJ.
• Demonstrated experience with CAPA execution and root cause analysis.
• Working knowledge of FDA (21 CFR 820/QMSR) and ISO 13485 quality systems.
• Ability to execute data-driven investigations and communicate findings across functions.

Culture & Benefits

• Competitive base salary with a targeted 10% annual bonus.
• Opportunity to work with life-saving technology in a diverse global environment.
• Focus on professional development and career growth.
• Hybrid work arrangement (1-2 days from home).