Requisition ID: 35285
At Terumo Blood and Cell Technologies, our 8,000+ 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’s 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 Title:
Functional Manager. Supplier Quality Management
1.2. Job Summary
A Leads the Global Supplier Quality Management team supervising detailed work of quality specialists on Approved Supplier List administration and supplier management activities. The Supplier Quality Manager will play an integral role in interpreting regulations and standards into Terumo BCT policies and procedures, and owning the ongoing maintenance, execution, and improvement of Supplier Management activities. Responsibility spans processes governing the global supply base of Terumo BCT, including both direct and indirect suppliers. This position reports to the Director of Global Supplier Quality Engineering - Sustaining
1.3. Essential Duties
- Supplier Management areas of ownership and responsibility may include (as assigned): Supplier reassessments, supplier performance scorecards, supplier quality agreements, supplier audit management, and implementation of tools and systems that enhance the effectiveness of the Supplier Quality function.
- Manages and provides operational leadership for the functional group's development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.
- Implements a common Approved Supplier List (ASL) for Terumo BCT sites and mechanisms to manage supplier additions/removals.
- Contributes to the implementation of global supplier processes.
- Drives activities to establish and maintain a global supplier scorecard process.
- Completes and/or facilitates completion of the periodic reassessment of suppliers to remain on the ASL.
- Reviews new Supplier Quality Agreements and manages the upkeep of existing agreements across all Terumo BCT sites.
- Monitors the health of Global Supplier Quality KPIs and provides metrics to management as required, including any governing oversight boards.
- Establishes supplier performance tools such as benchmarking dashboards, heat maps and control plan templates.
- Supports quality initiatives aimed at developing and improving business systems; may be the primary representative of Supplier Quality group on projects.
- Serves as a Subject Matter Expert to support Terumo BCT sites as needed during audits and inspections for the areas of Supplier and Purchasing Controls.
- Interfaces with Supplier Quality area owners at other Terumo BCT locations, regions, and corporations.
- Identifies and implements continuous improvement opportunities within their area(s) of responsibility.
- Implements and understands FDA or regulatory requirements as necessary.
- Ensures compliance with Quality System regulations and safe working practices.
1.4. Minimum Qualification Requirements
1.4.1. Education
Bachelor’s degree or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered. 1.4.2.
Experience
- Minimum 5 years’ experience.
- Preferred minimum 7 years’ experience in Quality Assurance and or Regulatory Affairs, involving US FDA Class II or Class III medical devices
- Minimum 2 years supervisory experience.
- Preferred training in FDA Quality System Regulation and ISO 13485
1.4.3. Skills
- Knowledge of U.S. and international medical device regulations and standards (CFR 820, MDR and ISO 13485).
- 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, quality specialists, and management.
- Solicits and accepts the ideas of others, as well as actively contributes to an environment conducive to open communication.
- Capability to interact with diplomacy and tact while maintaining appropriate assertiveness.
- Demonstrated ability to communicate effectively both verbally and in writing.
- Knowledge and use of relevant PC software applications and skills to use them effectively.
- Must be detail oriented, well organized and able to work independently and in teams.
- Demonstrated ability to lead people and get results through others.
-Or-
- An equivalent competency level acquired through a variation of these qualifications may be considered
1.5. Physical Requirements
General Labor Environment requirements include use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 25 kgs 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 accommodation may be made to enable individuals with disabilities to perform the essential duties.
1.6. Additional Requirements
Requires travel based on business needs.
Terumo Penpol is part of Terumo Group and is headquartered in Thiruvananthapuram, Kerala. As India’s largest blood bag manufacturer, we provide a comprehensive range of blood collection, storage and processing solutions for blood centers, hospitals and therapeutic apheresis centers in India and abroad. Our high-quality products touch the lives of patients in over 80 countries across the world.
True to our mission of contributing to society through healthcare, our award-winning Corporate Social Responsibility initiatives reinforce our organizational values and culture. Firmly rooted in core values collectively termed as the ‘Associate Spirit’, our work culture fosters an environment conducive to growth and continuous learning. People are our greatest asset, and we place as much importance in their professional development as in the research and development of our products.
Job Segment: Medical Device, R&D Engineer, CSR, R&D, Quality Assurance, Healthcare, Engineering, Management, Research, Technology
