Changing lives. Building Careers.
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.
Key Duties and Responsibilities
- 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.
Education and Experience
- 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.
Essential Skills and Abilities
- Excellent verbal and written communication skills (Japanese and English).
- Strong analytical and problem-solving skills related to technical investigations and quality issues.
- Ability to collaborate with cross-functional teams including Service engineers and global teams.
- Understanding of ISO13485 quality system requirements and medical device regulatory frameworks.
- Ability to manage multiple priorities and work independently in a regulated environment.
Unsolicited Agency Submission
Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.
