Director Product Quality Western Hemisphere

at Terumo BCT

Lakewood, CO

Posted on Apr. 29, 2017

STATE: Colorado (US-CO)
COUNTRY: United States

JOB SUMMARY
This individual will hold responsibility for ensuring the development, establishment, global deployment and maintenance of Quality Management Systems programs, policies, processes, procedures and controls across multiple factories. Work towards improving quality of products to provide lasting customer satisfaction and to ensure on-going conformance to established applicable standards, regulations and agency guidelines.

ESSENTIAL DUTIES AND RESPONSIBILITIES
PRODUCT QUALITY :

* Responsibilities include influencing and driving teams in the areas of process improvements, trend monitoring and correlating leading quality metrics, problem solving approaches, and data analysis. Leads root cause analysis of complex systems issues.
* Develops and reports and improves on metrics related to QMS
* Evaluate changes to products ensuring that the implications of changes are fully understood
* Leads Management Review for factory.
* Constantly analyze changing business and customer needs and propose organizational or systems changes to address these needs. Recommends changes to other areas that will improve overall effectiveness.

PROCESS AND SYSTEMS:

* Responsibilities include factory complaint investigation processes, internal audit processes, and CAPA processes. Works with manufacturing, engineering, and other functional groups on regulatory compliance issues. Develops or participates in the development of solutions to problems of moderate to high complexity. Interprets, executes and recommends modifications to operating policies where appropriate.
* Serves as Management Representative (MR) for FDA responsibilities.

FACILITATION AND RELATIONS :

* Develops/maintains constructive relationships with customers and other business entities served and ensure such relationships exist throughout the organization. Develops constructive relationships with each functional area served. Clarify and simplify problems and develop bridge-building solutions that improve relationships across all functions and processes in BCT.
* Facilitates the sharing of best practices across the company.
* Works with internal and/or external resources to resolve problems of exceptional complexity and sensitivity. May be primary representative of operations or quality group on projects or management teams.
* Works with intra-company entities and external resources to manage all areas of responsibilities including Operations, R determines assignments and changes employees' status in accordance with Terumo BCT policy.

BUSINESS PROCESSES :

* Ensures that activities are managed in accordance with Terumo BCT Standards of Business Conduct and appropriate business controls. Establishes and drives aggressive programs to improve the quality and productivity of systems, tools, training processes, and procedures.
* Prioritize and manage resources effectively to optimize the improvement of business processes across BCT.
* Understands business process issues and works together with business process leadership to resolve problems in the processes, procedures and policies, driving change where necessary. Accountable for operating policy for area of responsibility.
* Develop and effectively manage systems (People, Processes, Software) with a high degree of responsiveness and flexibility to meet the needs of customers and management.
* Influences short and long term business goals. Exerts influence on corporate objectives and long-range goals in areas related to QMS and compliance.

OTHER RESPONSIBILITIES :

* Manages the development and implementation of business objectives, strategies, processes, tools, and systems to improve quality and productivity, optimize customer satisfaction and return on assets, to meet business needs and ensure business controls. Responsible for internal and external audits and the product release process. May be involved with Group or company councils/ committees working on strategic initiatives and projects.
* Develops and directs implementation of plans for the purpose of achieving multi-functional and cross-functional goals intended to support business objectives through appropriate use of human and technology resources (internal and external).
* May lead problem-solving teams. Ensures subordinate participation on inter/intra organizational teams.
* Acts as consultant to management, marketing and industry representatives in a support role for product development & design, technical literature and technical/clinical support.

MINIMUM QUALIFICATION REQUIREMENTS

Education
Bachelors degree in Quality, Engineering, or a related discipline with 10+ years experience, and 5 years management experience, or a Masters Degree in Engineering, or a related discipline.

Experience
10 years experience and 5 year management experience, or an equivalent combination of education and experience.
Skills

* Demonstrated skills in leadership and development of people and teams. Capability to build and maintain effective working relationships across functions and organizations and levels.
* Demonstrated effectiveness with interpersonal skills and the ability to interface with Senior Management, internally and externally.
* Demonstrated expertise in planning, budgeting, personnel development, and project management directed toward achievement of annual, long term and strategic business plans and goals.
* Demonstrates a positive, direct, proactive approach to problem solving and impediments, mentors others to understand and model this approach. Constructive and relentless in pursuit of solutions. Motivates others to do the same.
* Understanding of customer needs, product technology, technical support, therapy, use and user market applicable to the area and the ability to determine appropriate actions.
* Requires understanding of quality management techniques and experience in developing quality goals and measures and directing others, including suppliers.
* Extensive knowledge of U.S. and international medical device regulations and standards.
* Thorough understanding of measures of customer satisfaction and experience in their implementation as a tool for continuous improvement.
* Ability to use and teach technology and methods necessary to facilitate Quality System design and continuous improvement across BCT, including process mapping and redesign, project management, metrics selection and monitoring.
* Strong communication skills: Meeting facilitation, verbal and written communication across all levels, cross-functional participation and influence, mentoring and acceptance of guidance, technical leadership, and project management.
* Ability to contribute at the global / strategic business level.
* Cultural and situational flexibility and adaptability is essential.
* Ability and success to routinely diagnose problems and recommend solutions through teamwork, failure mode analysis and other analytical techniques.
* Demonstrated knowledge and application of manufacturing protocols, statistical tools and methodology, and continuous improvement techniques.
* Demonstrated leadership and team skills.
* Demonstrated history of willingness to take ownership and accept responsibility for actions and decisions.
* Demonstrated interpersonal skills and the ability to interact with diplomacy and tact while maintaining appropriate assertiveness and persistence.
* Demonstrated ability to communicate effectively both verbally and in writing.
* Demonstrated problem solving ability - enjoys learning, seeks additional information

CERTIFICATES, LICENSES, REGISTRATIONS

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
There will be an occasional requirement to work outside of normal business hours, consistent with other Director-level positions.
US and International travel will be required at

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 .

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

IF YOU ARE THE BEST AT WHAT YOU DO AND WANT TO DO WORK THAT IS CHANGING THE DELIVERY OF HEALTHCARE GLOBALLY, WE INVITE YOU TO WORK WITH US NOW TO SEE HOW WE CAN UNLOCK YOUR POTENTIAL.
*CB*

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