Director, Quality Systems & Compliance

Company: Terumo Medical CorporationDepartment: Quality Systems & ComplianceTerumo 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.The Director, Quality Systems and Compliance is responsible for the design, development, deployment, and maintenance of the company’s Quality System. This individual is the primary interface with external regulatory agencies for audits and is responsible for ensuring our Quality System is continually compliant with all applicable regulations and standards including but not limited to U.S. Quality System Regulation, Japanese Pharmaceutical Affairs Laws, ISO 13485, the Canadian Quality System Regulation, and the European Union Medical Device Regulation (EU MDR).In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. Support the development of a proactive and preventive quality systems culture throughout the business.Manage and develop a team of quality systems and compliance managers. Establish a high-performing team to drive the organizational goals & objectives and instill quality culture.Develop, support, maintain, and continuously improve the TMC Quality system in accordance with applicable regulations for a global medical device corporation including, but not limited to, 21 CFR 820, ISO 13485:2016, EU Medical Device Regulation, and MDSAP.Ensure appropriate management oversight by organizing the Quality System Management Review and other key quality system governance boards.Manage Quality System audits with Regulatory Agencies and Notified Bodies. Ensure appropriate action and follow-up for open action items and/or effectiveness checks for items are addressed in a timely manner.Develop a learning culture throughout the organization. In conjunction with functional SMEs, develop effective, compliant, and engaging training material to meet global regulations.Job Responsibilities (continued)

Oversee the quality change management process in alignment with the global regulations.Direct the company’s post-market surveillance program, ensuring on-time adverse event reporting, trending, and corrective actions.Support TMC sites and subsidiaries on compliance and quality system related challenges.Follow all established Environmental Health & Safety and Quality System policies, programs, rules, and practices.Knowledge, Skills and Abilities (KSA)

Extensive experience with FDA, ISO 13485, EU MDR, MDSAP and global quality system requirements for medical devices.Strong analytical skills including trend and statistical analysis.Ability to use process development tools (ex. Lean Six Sigma).Demonstrated ability to communicate and interact with all levels of the organization including Executive Leadership.Strong interpersonal skills to provide coaching, training, and direction.Proven experience influencing across the organization to improve product or processes.Strong proofreading and writing skills, as well as exemplary attention to detail.Demonstrated organizational and prioritization skills.Exceptional decision-making including the ability to rapidly understand complex changes and pace work completion to the needs of the company.Strong computer knowledge (MS Office), technical writing skills, and proofreading ability.Demonstrated ability to work effectively with cross-functional teams for problem-solving, product, and process improvement.Qualifications/ Background Experiences

Requires a four-year degree in a technical/science/engineering field.Minimum 10 years' overall experience with at least 5 years of related experience in medical devices/diagnostics, pharmaceutical or other regulated industry required with a focus on quality systems.A minimum of 5 years in a supervisory/management role.

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