At Terumo Cardiovascular, we develop, manufacture and distribute medical devices for cardiac and vascular surgery with an emphasis on cardiopulmonary bypass, intra-operative monitoring and vascular grafting. This includes a full-line of perfusion products, endoscopic vessel harvesting products and surgical stabilization products.
Our mission is to work as a team to save one more life, today and every day. We do this by providing lifesaving technology to cardiac surgery teams around the world.
This position is responsible for ensuring compliance with global regulatory requirements, manufacturing standards, and internal procedures in order to facilitate the site in producing safe and effective products and execution/maintenance of the Site Quality System. This position is also responsible for ensuring the CAPA system is effectively executed and maintained.
This position also has the authority to perform as the Deputy Site Management Representative.
- 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.
- Serves as the process owner for Document & Record Control, Internal Audits, & CAPA which includes responsibility for ongoing management, maintenance and continuous improvement of each system, including processes and procedures.
- Establish and implement strategic direction for the CAPA, Document Control, Change Control and Internal Audit programs that are aligned with business and quality initiatives and in compliance with all regulatory requirements.
- Provide oversight for daily operation of the CAPA department, Document Control, Change Control and Internal Audit Departments. This includes providing guidance and direction of the CAPA functions by means of staff performance feedback, evaluation and development to ensure staff understand and are competent to perform their roles and responsibilities and are in compliance with required procedures
- Develop, implement, maintain and continuously improve Ann Arbor site external inspection processes (processes for hosting external inspection)
- Support and monitor the annual Site Quality Plan improvement efforts.
- Support the Management Representative as Quality Systems expert and support for regulatory/notified body inspections, customer audits and other third-party Quality System evaluations.
- Author, change, and update site Quality Manual and QA procedures as applicable.
- Support preparation, coordination and delivery of the site management review.
- Develop and maintain expertise in current industry CAPA, Documentation and Change Control, and Internal Auditing, including understanding of current technologies and trends, through actions such as professional memberships, attendance at conferences and/or seminars, subscription to trade magazines, etc.
- Prepare and analyze CAPA and Quality System data as required. Provide input data, including trending, for site, and Corporate Management Review.
- Perform other duties as assigned.
- Utilizes the systems and processes in place to attract, develop, engage, train and retain talented Associates; creating a work environment where Associates can realize their full potential, thus allowing the organization to meet business needs.
Qualifications/ Background Experiences
Requires a four-year college degree and a minimum of eight years of experience working in a combination of quality systems and CAPA in a regulated medical device, manufacturing, biotech, or pharmaceutical environment, of which a minimum of two years must be supervisory experience. Masters degree preferred. Experience with Six Sigma Process Excellence tools, training, and/or certification preferred. Intermediate computer software skills, i.e., Microsoft Office.
Terumo Cardiovascular is an equal opportunity employer. We promote recognition and respect for individual and cultural differences, and we work to make our employees feel valued and appreciated, whatever their race, gender, sex, sexual orientation, gender identity and/or expression, and genetic information.
Nearest Major Market: Ann Arbor
Nearest Secondary Market: Detroit