QMS Manager - Design Controls and Risk

at Terumo BCT

Lakewood, CO

Posted on Nov. 29, 2016



Provides leadership to the company in the process of building, implementing, maintaining and monitoring a global compliant Quality Management System by applying an advanced level of understanding of international regulatory requirements and industry standards. The primary responsibility of the position is to lead the design, review and implementation of the new Global Quality System, and own respective processes once implemented in order to maintain one Global QMS. Secondarily, the resource will manage, coordinate, and successfully execute plans for the future state Quality Management System, including the design of processes and the implementation of technology. Adheres to Terumo BCT practices for project governance, assists with evolution of Terumo BCT and communicates important milestones and achievements as well as risks as they relate to projects.


* Manage design, implementation, maintenance and monitoring of global quality system in accordance with department, regulatory, and professional standards for compliance.

* Serves as expert and main point of contact for global regulations, standards and processes within area of responsibility.

* Acts as the global policy / procedure and Quality System technology requirements Corporate QMS steward/owner for area(s) of responsibility, ensuring they are compliant and effective.

* Facilitates and coordinates workstream activities and tasks to support the execution of the QMS design project plan and maintenance of changes.

* Manages scope and schedule for the workstream and drives to quality on time completion for initial design, implementation and ongoing changes.

* Ensures proper assignment and coordination of extended team and resources per project execution plan.

* Facilitates the definition of quality and risk, and manages the project accordingly. Resolves and/or escalates project-related issues in a timely fashion.

* Tracks status and metrics on the project delivery and value; escalates to functional management upon identification of deviations (or potential deviations) from plan.

* Effectively manages communications, expectations, and interactions with all departments and internal stakeholders.

* Delivers informative, well-organized presentations on project status and selected project topics.

* Effectively utilizes each team member to accomplish the project objectives.



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

* Bachelor of Science Degree in Engineering, preferred.

* Minimum 10 years experience in Quality, Regulatory Affairs, Manufacturing or Engineering within regulated industry (e.g. medical device, pharmaceutical).
* Knowledge and experience interpreting and applying global regulations and standards for Quality Management System.

* Extensive knowledge of and experience in the following areas (within area of responsibility):

* Quality System elements including Management Controls, Document Management, Material Controls and CAPA
* Quality System elements including Production and Process Controls (e.g. Sterilization, Facilities Controls, Equipment Controls, Validation, Acceptance Criteria
* Quality System elements including Design Controls and Risk Management

* Successful completion of global projects involving stakeholders from multiple regions (North America, Latin America, Asia-Pacific, EMEA) strongly preferred.


* Demonstrated skill ability to develop and implement compliant and efficient processes.
* Strong interactive skills in cross functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross functional team member, team behavior, and support for subordinates, junior engineers, technicians, and management.
* Represents the organization as the prime technical contact on the work stream. Interacts with senior level external associates on significant design work, requirements gathering and review.
* Driver for acquiring resources and building consensus across projects.
* Solicits and accepts the ideas of others, as well as actively contributes to an environment conducive to open communication.
* Regularly and effectively presents complex technical information/analysis, and responds to questions from technical staff members and management.
* Demonstrated ability to communicate effectively both verbally and in writing.
* Ability and willingness to work on multiple topics at one time.
* Demonstrated ability to effectively lead and manage core teams.
* Demonstrated ability to develop and maintain the overall project vision and strategy while managing the tactical details and activities.
* Demonstrated facilitation skills to effect project progress per plan.
* Ability to manage conflicts; to read situations quickly; to lead by influence; to exploit opportunities; and to find common ground and get cooperation with minimum noise.

* Knowledge and use of relevant PC software applications and skills to use them effectively, including Microsoft Project schedules

An equivalent competency level acquired through a variation of these qualifications may be considered.
The area of responsibility is Risk Management and Design Controls. This includes the following duties and preferred skills:

* Manage design and implementation of the Risk Management and Design Controls processes within a new global quality system in accordance with department, regulatory, and professional standards for compliance (ISO 13485:2003, ISO 14971, MDD, CMDR, FDA Quality System Regulations).

* Comprehensive knowledge of U.S., European and other international regulations, standards and guidance applicable to medical devices and pharmaceuticals (e.g. ISO 13485:2016, ISO 14971:2012, 21 CFR 803, 21 CFR 820, 21 CFR 210 & 211, ICH Q7, MDD, MEDDEV 2.12, MHLW, etc.).

* Serves as expert and main point of contact for global regulations, standards and processes within area of Risk Mangement and Design Controls, ensuring processes are compliant and effective.

* Develops and implements risk based strategy for procedures and processes across the company as they relate to Verification and Validation activities, acceptance criteria, production processes and controls including material/supplier control, CAPA/post market activities, and regulatory changes and impacts.

* Successful completion of global projects involving stakeholders from multiple regions (North America, Latin America, Asia-Pacific, EMEA) preferred.

* Capability to interact with diplomacy and tact while maintaining appropriate assertiveness.

* Ensure interface and alignment throughout the product realization process and during the entire product life cycle including post-market surveillance for consistent decision making and actions across all functional areas.

* Experience with Essential Design Outputs and Critical component criteria preferred.
* Candidates with experience in embedded product software or stand alone software preferred.

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 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. For more information about Terumo BCT, visit our website www.terumobct.com/careers .

COUNTRY: [[mfield2]]

JOIN TERUMO BCT AS WE UNLOCK THE POTENTIAL OF BLOOD. We are a global leader in blood component and cellular technologies, and the only company with the unique combination of apheresis collections, manual and automated whole blood processing, and pathogen reduction coupled with leading technologies in therapeutic apheresis and cell processing. We believe in the potential of blood to do even more for patients than it does today. This belief inspires our innovation and strengthens our collaboration with customers.

As the largest medical device manufacturing company headquartered in Colorado, we are home to more than 2,300 associates and our products are in use in more than 125 countries and territories. Our Global footprint includes more than 5,500 associates and partners with regional headquarters in Brussels, Buenos Aires, Hong Kong and Tokyo.

Our company has almost $1B in annual revenues and has been voted and recognized as:

* Largest corporate sponsor in Rocky Mountain Region for Leukemia and Lymphoma Society (LLS)
* Winner of the Association for Talent Development (ATD) BEST Award for providing exceptional employee learning and talent development (2011 & 2012)
* One of Colorado's Healthiest Employers by Denver Business Journal (2014 & 2015)
* Recipient of the Way to Go Employer award through the Denver Regional Council of Governments (DRCOG) 2015

Our award-winning culture embraces:

* Leading technology through innovation and R&D
* Wellness programs
* Commitment to quality
* An environment that values, respects and rewards your individual contributions
* A philosophy of intentional growth and responsiveness to world health issues

Click Here to see what our associates have to say about our culture.

Each associate has a positive impact on our future by:

* Connecting to the lives of the patients we ultimately serve
* Growing through professional and leadership development activities
* Sharing company success through incentive plans


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