Requisition ID: 30721

At Terumo Blood and Cell Technologies, our 7,000+ global associates are proud to come to work each day, knowing that what we do impacts the lives of patients around the world.

We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient\xe2\x80\x99s life every second of every day and are committed to continuing to increase the number of patients we serve.

With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Consider joining our team and unlock your potential.

JOB SUMMARY

Working without significant direction, provides leadership to the company in maintaining a compliant Quality Management System by applying an advanced level of understanding of international regulatory requirements and industry standards (e.g., FDA, ISO, MDSAP, EUMDR etc.). This is primarily accomplished through routine and special request internal audits conducted globally by which the Auditor documents and reports to management on the company\'s state of quality system compliance. A secondary responsibility is to support external audits of the quality system by 2nd party auditors. A third responsibility is to provide consultative services within the organization in addressing compliance issues which may include research, architecture planning, analysis, design, validation, maintenance, support, training, of Quality Systems, Policies, and Procedures.

ESSENTIAL DUTIES

Manage all phases of global quality system compliance audits in accordance with department, regulatory, and professional standards for compliance against US and international regulatory requirements and standards (e.g. FDA and ISO).
Maintain current knowledge of global industry requirements.
Investigate potential compliance issues and advise management in a pro-active manner; coordinate the resolution of subsequent corrective actions.
Develop, or participate in the development of, solutions to quality system problems of intermediate to high complexity aimed at improving business systems and compliance; may be the primary representative of Quality group on projects.
May provide input to the functional group\xe2\x80\x99s development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.
Manage information availability for global audits and provide information to sites as needed during inspections and audits.
Manage audit records within the company\'s software system (PTC Windchill) to allow trending of outcomes.
Other duties as defined by manager.

OTHER DUTIES AND RESPONSIBILITIES

Work as team member with peers and other levels within entire organization and with external peers.
Develop, report and improve metrics related to QMS; analyze and trend quality system data and present to management as needed.

MINIMUM QUALIFICATION REQUIREMENTS

Education

Bachelor\xe2\x80\x99s degree or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.

Experience

Minimum 7 years of experience working within medical device, pharmaceutical etc industries.
Preferred minimum 3 years internal audit experience in Quality Management Systems involving US FDA Class II or Class III medical devices.
Preferred Direct contact experience hosting audits by FDA investigators and or ISO registrars.
Experience working with PTC Windchill or other similar electronic QMS is preferred.
Preferred training in FDA Quality System Regulation and ISO 13485

Skills

In-depth knowledge of U.S. and international medical device regulations and standards (CFR 820, MDD and ISO 13485).
Extensive knowledge of audit fundamentals and ability to conduct compliance audits.
Strong interactive skills in cross functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross functional team members, team behavior, and support for subordinates, peers, and management.
Ability to establish and maintain effective work relationships with associates, external auditors and consultants.
Capability to interact with diplomacy and tact while maintaining appropriate assertiveness; constructively deal with natural tension inherit in the audit processes.
Demonstrated ability to communicate effectively both verbally and in writing on a global basis.
Knowledge and use of relevant PC software applications and skills to use them effectively.
Must be detail oriented.
Demonstrated ability to lead people and get results through others.
Good planning, project management and organizational skills with an ability to balance multiple priorities at one time under limited direction.
Results-oriented individual with strong influencing, collaboration, problem solving and negotiation skills.
Strong technical writing ability, including appropriate presentation skills.

Certificates, Licenses, Registrations

ISO 13485 Lead Auditor Certification

• Or-

An equivalent competency level acquired through a variation of these qualifications may be considered.

PHYSICAL REQUIREMENTS

Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.

The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Additional Physical Requirements

Requires domestic and international travel up to 25%.

Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan.
In 2019, Terumo Blood and Cell Technologies reached $1 billion in revenue.
We employ nearly 7,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.
We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries.
Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare.
Respect \xe2\x80\x93 Appreciative of others
Integrity \xe2\x80\x93 Guided by our mission
Care \xe2\x80\x93 Empathetic to patients
Quality \xe2\x80\x93 Committed to excellence
Creativity \xe2\x80\x93 Striving for innovation

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