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

• Responsible for establishing and maintaining QMS documents (SOPs/Forms) to ensure compliance with the latest Japanese QMS requirements.
• Provide training and guidance on QMS requirements to employees involved in activities under the Japan QMS.
• Maintain quality and regulatory certifications, licenses, and registrations, including ISO 13485 certification, MAH license, and manufacturing licenses.
• Lead and coordinate internal and external QMS audits and inspections.
• Manage quality oversight of foreign manufacturers, including FMR maintenance, Quality Agreements, and periodic evaluations.
• Provide oversight of incoming inspection, product release, and labeling activities to ensure compliance with the Japan QMS.
• Manage nonconformance, complaint investigations, and CAPA activities.
• Coordinate and manage product recalls.
• Supervise QA personnel and provide guidance on quality and compliance matters.
• Investigate quality and compliance issues and drive continuous improvement activities.
• Ensure that quality-related activities are conducted in compliance with applicable regulations and company procedures.
• Review and approve quality records, change controls, deviations, CAPAs, and field actions as required.
• Support Management Review activities and monitor Quality System performance.

Education and Experience

• Bachelor’s degree in Chemistry, Biology, other technical/scientific area.
• Experience as a Hinseki in Medical Device industries preferred.
• Minimum of 8 years of experience in Quality Assurance within the medical device industry, including experience with Class III and/or Class IV medical devices.

Essential Skills and Abilities

• Excellent verbal and written communication skills. (Japanese and English)
• Ability to effectively communicate and negotiate with regulatory authorities, including MHLW, PMDA, local authorities, and certification bodies.
• Good organization skills and ability
• Ability to think strategically and enterprise-wide to ensure compliance and business needs.

Competencies

• Business level English
• Computer skills – MS-Word, Excel, PowerPoint

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.