Quality Engineer

We are seeking Quality Engineers with strong hands-on experience troubleshooting electro-mechanical medical devices in a fast-paced manufacturing environment. This role is critical to supporting production lines, ensuring compliance, and driving continuous improvement in a regulated medical device setting.

Key Responsibilities

• Production Line Support: Provide direct support to manufacturing operations, ensuring smooth production of medical devices.
• Troubleshooting: Perform hands-on diagnostics and repair of electromechanical systems, identifying root causes and implementing corrective actions.
• NCE Investigations: Lead non-conformance event investigations, develop containment strategies, and conduct risk assessments.
• CAPA & Risk Management: Execute corrective and preventive actions, ensuring compliance with FDA/GMP and ISO 13485 standards.
• Documentation Review: Review Device History Records (DHR) and quality documentation for accuracy and compliance.
• Collaboration: Partner with Manufacturing and Production Engineering teams to resolve quality issues and improve processes.

Requirements:

• Proven experience as a Quality Engineer in the medical device industry
• Strong hands-on troubleshooting of electro-mechanical devices
• Experience with NCE investigations, CAPA, containment, and risk assessments
• Background in production/manufacturing support
• Knowledge of DHR review and quality documentation
• Electrical engineering or electrical systems background preferred
• Previous Medtronic experience is a huge plus

Preferred Qualifications:

• Experience with Medtronic or similar medical device companies
• Background in FDA/GMP regulated environments
• Strong familiarity with medical device manufacturing processes

Additional Information:

• 100% On-Site role in Newark, NJ
• Weekend/Saturday support required based on production needs
• Immediate interview and quick onboarding process