Dir. of Quality Syst Compliance - QAD

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

This position is responsible for assisting the Vice President of Quality Systems Compliance in directing and conducting Quality Management System (QMS) and Product Quality / Shokiryudo assessments at Terumo facilities that manufacture products for the US market to confirm compliance with applicable US & international regulations / standards (such as 21 CFR (including Parts 7, 11, 211, 801, 803, 806, & 820); Canadian MDR; Japanese Ministerial Ordinances; ISO 13485; the Medical Device Directive; & EU-MDR).  This position is, also, responsible to assist with reporting the results of such assessments to the management staff at the local facility for purposes of determining the appropriate corrective actions that may be necessary to bring the QMS &/or production processes into substantial compliance with applicable US & international regulations / standards.  In addition, this position is responsible to facilitate communication with Terumo affiliates, as well as assist with reporting the individual & aggregate assessment results to Terumo Corporation (TC) management for awareness of the relative regulatory compliance risks, which could result in some sort of regulatory enforcement action.

This position is responsible for properly completing all assigned corporate assessment activities & assisting to assure that management is effectively informed of requirements that are necessary to establish / maintain compliance with applicable US & international regulations / standards.  Maintaining regulatory compliance is important because failure to do so can result in remedial actions ranging from internal QMS corrective actions, to product recall from the market, to litigation, &/or regulatory action by the FDA to address the situation.   This position is responsible for activities that may affect the operation of a single Terumo facility, or the entire corporation, with regards to addressing issues with a Notified Body, the FDA, or other regulatory agencies.  When appropriate, this position may assist with directing changes in company policy to ensure product safety, product effectiveness, ethical behavior &/or compliance with applicable regulations.
 

Job Details/Responsibilities

1.    Maintain training and follow applicable quality system procedures.
2.    Maintain up-to-date knowledge of applicable national / international QMS/GMP regulations, standards, guidelines and regulated industry trends.
3.    Investigate, audit, analyze, propose improvements and direct the assigned Quality Management System activities.
4.    Assist to establish, organize, monitor, & obtain agreement on the annual QAD / CQO Staff Quality Management System (QMS) & Product Quality Assessment Program in coordination with QAD / CQO Staff in Japan, as well as Quality Management staff at various Terumo facilities.
5.    Assist to direct & conduct Product Quality / Shoki-Ryudo & QMS assessments of Terumo facilities that manufacture products distributed in the US.
a.    Assessments will include supervision of global audit team resources, & collaboration with consultant support, when deemed