Director Quality Operation

At Terumo Aortic, our mission is to transform the treatment of aortic disease worldwide. With our comprehensive portfolio of surgical, endovascular and hybrid technologies, we enable physicians to find the right fit for each patient anatomy.

The company has over 1,250 associates around the world with manufacturing facilities in Glasgow, Scotland and Sunrise, Florida.

Terumo Aortic is focused on the continuing development of new and innovative products driving the growth of the business globally. Associates are part of a stimulating and exciting environment in which they can develop their skills and achieve career goals. Working for the company, each associate’s role contributes greatly to helping to save or improve the lives of patients in over 100 countries worldwide.

www.terumoaortic.com

Director Quality Operation

Job Summary:

This position is responsible for managing all aspects of quality operations within the manufacturing facility. The position is also responsible for ensuring compliance with the applicable regulations of all countries in which Terumo Medical manufactures or distributes products including, but not limited to the U.S. Quality System Regulation, Japanese Pharmaceutical Affairs Laws, the Canadian Quality System Regulation, MDSAP and the Medical Device Regulation (MDR).

Job Details:

1. In all actions, demonstrate 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.
2. Establish a high-performing team to drive the organizational goals & objectives and instill quality culture. Drive engagement to ensure personnel have clear expectations, appropriate tools and information, an opportunity to share, grow and develop and team members are recognized for their contributions.
3. Appointed Quality Management Representative who provides overall Quality Systems leadership including ensuring establishment and maintenance of a Quality system which is compliant with appropriate US and international regulations as well as Terumo Corporation’s Quality Policies. Report on the performance of the quality system to management with executive responsibility for review, in both periodic management review meetings and as needed.
4. Partner with operations and engineering functions to establish site level strategies in alignment with corporate. Appropriately prioritizes sustaining work with project work to ensure timely product release, reduction of nonconformances, and other operational improvements.
5. Function as a champion of Six Sigma, Lean, Kaizen, and Gemba within the facility. Drive methodical problem solving and process improvement of quality systems and manufacturing processes. Support the development of quality strategies, initiatives and measure for the business and site as a member of TMC Quality Leadership team.
6. 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.
7. Follow all established Environmental Health & Safety and Quality System policies, programs, rules, and practices, including but not limited to product and patient safety, the health and safety of all associates as well as the environment and community at large.
8. Performs other job-related duties assigned.

Working Conditions: 

Travel 15%

Remote Work 0%

Position Requirements:

• Knowledge, Skills, and Abilities (KSAs)
• Quality and business process knowledge
  • 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)
• Leadership skills:
  • Demonstrated ability to communicate and interact with all levels of the organization including Executive Leadership.
  • Strong interpersonal skills to provide coaching, training, and direction.
  • Demonstrated ability to provide clear direction and mentor personnel.
  • Proven experience influencing across the organization to improve product or processes.
• Individual skills required:
  • 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.
  • Demonstrated initiative and ability to work independently while managing multiple tasks.

• Demonstrated ability to work effectively with cross-functional teams for problem-solving, product and process improvement is required.
  
  

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 five years’ experience in a supervisory / management role.

It is Terumo’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.