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
