Quality Systems Compliance Auditor

at Terumo BCT

Denver, CO

Posted on Sep. 7, 2016

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). 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 2 nd or 3 rd 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, and implementation of Quality Systems, Policies, and Procedures.


* 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).
* Partner with Supplier Engineering to maintain and improve supplier quality audit program to fulfill the requirements of Terumo BCT Quality Management System including compliance to international requirements and standards
* Partner with Supplier Engineering to create and execute supplier audit schedule
* Partner with Supplier Engineering to perform Supplier Audits
* Review and approve audit reports and assure appropriate Supplier Corrective Actions (SCA) are assigned to address cited nonconformities
* Review and approve Supplier Quality Agreements
* Review and approve SOPs and Work Instructions to ensure adequate documentation and execution of the company's Supplier Audit Program
* Generate metrics for the measurement and analysis of supplier audit program
* Maintains appropriate knowledge of current QSR regulations, ISO standards and other external regulations and standards
* Conduct reviews and perform audits resulting in documentation, communication of findings and identification of risk

* Lead auditor certified
* Manage the interfaces with and/or direct others in interacting with global regulatory authorities, notified body registrars, customer auditors, and internal departments.
* Maintain current knowledge of FDA, ISO (including Risk Management), and 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 manage and provide leadership for the functional group's development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.


* Work as team member with peers and other levels within entire organization and with external peers.
* Review and approve changes to the quality system.

* Develop, report and improve metrics related to QMS; analyze and trend quality system data and present to management.

Bachelor's degree or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.

* Minimum 7 years experience.
* Preferred minimum 2 years internal audit experience in Quality Management Systems involving US FDA Class II or Class III medical devices.
* Direct contact experience hosting audits by FDA investigators and or ISO registrars.
* Preferred training in FDA Quality System Regulation and ISO 13485


* 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.

ISO 13485:2003 Lead Auditor Certification
An equivalent competency level acquired through a variation of these qualifications may be considered.
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.
Requires domestic and international travel based on business needs.
We are proud to be an Equal Opportunity Affirmative Action Employer. All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service.
We maintain a drug-free workplace and perform pre-employment substance abuse testing and background verification checks. As of January 1, 2017 the Terumo BCT Lakewood, Colorado location will be a tobacco-free workplace.

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