Sr. Quality Systems Documentation Specialist

Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world’s leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products.

We believe that the future is bright for everyone at Terumo. We work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to come.

At Terumo we believe in the power of personal growth and will encourage you to get in the driver's seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what's next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients.

Join us and help shape wherever we go next!

Advancing healthcare with heart

Job Summary

The Senior Quality Systems Documentation Specialist will be responsible for developing, managing, and maintaining the documentation necessary for the effective functioning of our quality management system. As a key contributor to our quality system processes, you will collaborate with cross-functional teams to ensure compliance with industry standards and regulatory requirements. Your expertise in quality systems documentation will be vital to driving continuous improvement initiatives and enhancing our overall operational efficiency. This position requires strong analytical skills, attention to detail, and a thorough understanding of quality management principles. You will play a significant role in training team members on documentation standards and methodologies, ensuring that all documentation is not only accurate but also easily accessible for internal audits and external inspections. The ideal candidate will have a proven track record in quality systems documentation, as well as excellent communication skills to convey complex information effectively. The ideal candidate will be passionate about maintaining high standards of quality and can thrive in a fast-paced environment.

Job Responsibilities (continued)

• Quality Data Analysis: Lead the development and maintenance of detailed quality metrics and reports. Analyze data to identify trends that inform continuous improvement initiatives and ensure compliance with regulatory standards.
• Document Control Management: Oversee the document control system, ensuring all documents are up-to-date, easily accessible, and fully compliant with company policies, ISO 13485, and FDA regulations.
• Document Review and Approval: Review, edit, and approve critical documents such as SOPs and work instructions, ensuring alignment with internal policies and external regulatory requirements.
• Documentation Creation: Lead the creation and maintenance of quality process documentation, including standard operating procedures and work instructions, to ensure clear, consistent, and compliant processes.
• Employee Training: Develop and deliver training on quality processes and systems, enhancing team competencies and ensuring compliance with established standards and procedures.
• Quality System Documentation Oversight: Maintain comprehensive quality documentation throughout the product lifecycle, ensuring it aligns with ISO 13485 and FDA regulatory requirements.
• Compliance Monitoring: Monitor and track document revisions and approvals, ensuring continuous adherence to regulatory requirements and internal procedures.
• Audit Support: Provide critical support during internal and external audits, ensuring all documentation is audit-ready and compliant, and assisting with auditor inquiries.
• Cross-Department Collaboration: Coordinate with departments across the organization to ensure accurate and timely documentation of quality events, fostering collaboration and consistency.
• Policy Development: Assist in the creation, revision, and updating of quality policies and procedures, ensuring they meet both regulator