at Terumo BCT
Posted on Sep. 15, 2017
JOB TITLE: SR MANAGER QUALITY MANAGEMENT SYSTEMS - DESIGN CONTROLS
Leads the activities for the development, implementation, monitoring and continuous improvement of Quality Management System programs, policies, processes, procedures and controls to achieve the company's objectives. Works closely with all other departments and business areas to ensure an effective and compliant quality system.
Position oversees Global Design Controls Procedures and Processes, collaborating closely with Innovation and Development.
DUTIES AND RESPONSIBILITIES
* Provides operational leadership for the architecture, process, optimization and consistency of Design Controls.
* Collaborates with global I facilitates sharing best practices across regional locations.
* Ensures that the Quality Management System is established, implemented and maintained for effectiveness in accordance with applicable standards within scope of Design Controls (including but not limited to FDA Quality System Regulations 820.30, ISO 13485, ISO 14971:2012, MDD, MDR, CMDR).
* Supports continuous improvement of Design Controls by leading implementation efforts to new and changing requirements and process improvement initiatives.
* Supports external regulatory compliance audits and relationships with industry groups, regulatory agencies and customers (e.g., FDA, Notified Bodies, Customers, Health Canada and other international regulatory agencies).
* Collaborates with I&D to develop, implement and monitor I&D management control metrics
* Works cross functionally to develop, implement and maintain effective training programs to achieve and maintain quality system and regulation awareness, ISO certifications and Quality System compliance related to design controls.
MINIMUM QUALIFICATION REQUIREMENTS
* Bachelor's degree or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
* Masters Degree in Engineering or related discipline is preferred.
* Minimum 10 years experience in Quality /Quality Control function, with at least 5 years direct experience in the medical device manufacturing industry.
* Preferred minimum of 5 years Regulatory Compliance/Regulatory Affairs experience involving US FDA Class II or Class III medical devices.
* Demonstrated practical experience working with Product Development teams to develop quality assurance plans and Design and Development plans that balance operational effectiveness and compliance.
* Experience in interfacing with global regulatory agencies (USFDA and or Notified Body inspections, audits or other similar regulatory body inspections).
* Comprehensive knowledge of U.S., European and other international regulations, standards and guidance applicable to Design Controls activities for medical devices (e.g. ISO 13485, 21 CFR 803, MDD, etc.).
* Formal Design Controls training
* Must have strong theoretical knowledge of Design Controls, including in-depth practical knowledge of how to apply these principles.
* Extensive knowledge of U.S. and international medical device regulations and standards.
* Proven ability to solve practical problems in a collaborative manner which yields effective compliance with QMS and external standards while allowing for the use of efficient and flexible implementation approaches.
* Proven ability to interact with senior management team, including influencing other members in matters of significance to the organization.
* Demonstrated ability to organize and motivate cross-functional and multi-facility teams to meet quality goals. Ability to communicate and work effectively as a team member and colleague within functional team processes such as CAPA and audits.
* Excellent written and oral communication skills and a proven ability to communicate effectively. Proven ability to read and interpret documents of significant complexity, including external standards, design inputs, verification/validation protocols, and clinical studies.
* Ability to use and teach methods necessary to facilitate Quality System design and continuous improvement across the company (e.g. six-sigma, process mapping and redesign, project management, metrics selection and monitoring, etc).
CERTIFICATES, LICENSES, REGISTRATIONS:
Six Sigma Black Belt desirable.
* There will be occasional requirement to work outside of normal business hours, consistent with other positions at this level.
* Some US and international travel will be required (
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
In the typical office environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.
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, Singapore 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.