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Service & Repair Quality Engineer
Integra LifeSciencesQuality Engineer supporting the integration of Service and Repair documentation into Japan QMS. Conducting investigations and ensuring compliance with medical device regulations in Japan and Korea.
About the role
Key responsibilities & impact- Support the integration of Service and Repair documentation and processes into the Japan QMS framework.
- Provide quality support for Service and Repair operations and review service documentation, repair records, and service procedures as necessary.
- Conduct complaint investigations related to repairable capital equipment, and lead root cause analysis and quality investigations.
- Lead Post-Market Surveillance (PMS) activities related to repair complaints, including analysis of service history, repair data, and complaint trends, and drive quality improvement initiatives.
- Support Non-Conformance and CAPA activities related to S&R operations in collaboration with Global S&R Quality.
- Work closely with Global S&R Quality to ensure alignment with global quality requirements and best practices.
- Support quality compliance for S&R operations in Japan and Korea, ensuring compliance with applicable regulations and QMS requirements, and promoting continuous improvement.
- Review service procedures and operational practices from a quality perspective and provide recommendations to ensure compliance with QMS requirements.
- Identify opportunities to improve QMS operations and systems and drive continuous improvement.
Requirements
What you’ll need- Bachelor's degree in Mechanical Engineering, Statistics, Engineering, or other technical/scientific discipline preferred.
- Minimum of 3 years of experience in the medical device industry in quality assurance, service engineering, repair operations, or other technical roles.
- Qualification as a Responsible Engineer for medical device repair under Japanese regulations preferred.
- Experience in technical troubleshooting or failure investigation of capital medical devices preferred.
- Knowledge of Japanese medical device regulations related to repair business and quality management preferred.
- Familiarity with repair practices in Korea and knowledge of medical device regulatory requirements preferred.
Benefits
Comp & perks- Health insurance
- Professional development opportunities
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
quality assuranceroot cause analysisPost-Market SurveillanceNon-ConformanceCAPAtechnical troubleshootingfailure investigationrepair operationscontinuous improvementQMS compliance
Soft Skills
collaborationcommunicationleadershipanalytical skillsproblem-solving
Certifications
Bachelor's degree in Mechanical EngineeringResponsible Engineer qualification