Manager, Supplier Quality

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Date: Mar 23, 2024

Location: Littleton, CO, US

Company: Terumo BCT, Inc.

Requisition ID:  31840  

 

At Terumo Blood and Cell Technologies, our 7,000+ global associates 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. 

Leads Supplier Quality Engineering and Receiving Inspection teams, supervising detailed engineering work and inspection activities.  The Supplier Quality Manager plays an integral role in managing supplier quality interactions and ensuring Supplier Controls compliance.  This includes interpreting regulations and standards into Terumo BCT policies and procedures, and owning the ongoing maintenance, execution, and improvement of QMS areas of responsibilities. Duties are assigned to provide experience and familiarization with engineering methods, independent thinking, and company practices and policies.

 

ESSENTIAL DUTIES

  • Areas of ownership, management, and responsibilities include receiving quality assurance and supplier quality engineering.
  • Serves as expert and main point of contact for regulatory/compliance issues within area of responsibility, including serving as Subject Matter Expert and Process owner for QMS areas of responsibility during audits and inspections.
  • Manages team of direct reports in supplier quality and receiving inspection. Plans, guides, and reviews tasks and projects to produce the desired outcome.
  • Manages projects related to the continuous improvement of raw-materials quality management processes.
  • Supports the identification and resolution of component defects through nonconformance, CAPA and supplier corrective action processes.
  • Manage, continuously improve, and provide oversight to appropriate incoming inspection test methods, acceptance sampling plans, measurement system analysis, and raw material nonconformance board
  • Manages improvements to raw-material quality through supplier process improvements, and supplier corrective actions.
  • Ensure all Supplier Quality team members have sufficient training and knowledge to execute their tasks.
  • Approves disposition of nonconforming product, CAPA, supplier corrective actions, and supplier changes related to product and process.
  • During audits and inspections, interfaces with global regulatory authorities, notified body auditors, and provide general support for the Quality group.
  • Actively participates in the annual budgeting process and may be responsible for managing an operation within budgetary guidelines.
  • Develops and maintain KPIs for supplier quality and receiving inspection teams. Ensures business-sense sufficient resource planning and allocation.
  • Creates, maintains, and analyzes data for functional area.
  • Monitors and executes their QMS area(s) in accordance with governing internal policies / procedures and external standards and regulations. This likely includes generation and approval of the annual schedules, execution to schedule, approval of plans or reports, follow up on action items, facilitation of discussions with participants and stakeholders to ensure success and compliance.
  • Influences the organization in quality objectives, prioritization, and resourcing decisions as necessary.
  • Utilizes technical skills to evaluate proposed solutions, adaptations, and modifications to projects.
  • 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.
  • Acts as an internal champion for quality initiatives aimed at improving business systems and compliance; may be the primary representative of Quality group on projects.
  • Interfaces with QMS area owners and project team from other Terumo BCT locations and regions.

 

 

MINIMUM QUALIFICATION REQUIREMENTS

 

Education

  • 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.

 

Experience

  • Minimum 10 years’ experience.
  • Preferred minimum 7 years’ experience in Quality Assurance and/or Regulatory Affairs, involving US FDA Class II or Class III medical devices including knowledge & experience of applying global device laws & regulations.
  • Preferred 2 years or more of supervisory experience.
  • Preferred training in FDA Quality Systems Regulation and ISO 13485.
  • Preferred experience with inspection via hand tools (calipers, gage pins, etc), CMM, OGP, Keyence Optical Comparators, and Keyence Confocal Microscopes.
  • Preferred experience programming inspection equipment.
  • Preferred experience with statistical rationale for sampling plans.

 

Skills

  • Strong leadership capabilities to ensure continuous guidance, coaching, and directing teams to success in their tasks and professional development.
  • Strong project management, problem-solving, resource management skills.
  • Demonstrated skills in developing, coaching, and training others in an organizational setting.
  • Excellent in collaboration methodologies in working with cross-functional groups.
  • Understanding of GD&T, Gage R&R, and Correlation studies.
  • In-depth knowledge of ISO 13485, 21CFR820, and Supplier Quality Management requirements.
  • Demonstrated ability to interact with regulatory agencies.
  • Knowledge and experience in one or more of the following areas:
  • Metrology Engineering disciplines or technical training.
  • Data analysis methodologies.
  • Manufacturing Processes: statistics, math, or related engineering sciences.
  • Demonstrated ownership for customer service orientation and approach to problem solving.
  • Able to perform the highest level of complex testing, inspects raw materials using standard or custom tools, and conducts and reports quality assurance trends and metrics.
  • Knowledge and use of relevant PC software applications and skills to use them effectively.
  • Demonstrated ability to communicate effectively both verbally and in writing.
  • Extensive experience in working with suppliers of materials and services.

 

-Or-

An equivalent competency level acquired through a variation of these qualifications may be considered.

 

LOCATION

Littleton, Colorado (onsite)

 

 

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 50 pounds, or transporting up to 500 pounds via carts or mechanized equipment.
  • 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 Requirements

Requires travel based on business needs up to 25%.

 

 

Target Pay Range:  $117,400.00 to $146,800.00  -  Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data
Target Bonus on Base:  10.0%

 

At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family. Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more. To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates. For us, it’s about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind.

 

  • Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan.
  • In 2019, Terumo Blood and Cell Technologies reached $1 billion in revenue.
  • We employ nearly 7,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.
  • We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries.
  • Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare.
    • Respect – Appreciative of others
    • Integrity – Guided by our mission
    • Care – Empathetic to patients
    • Quality – Committed to excellence
    • Creativity – Striving for innovation
  • We contribute to the Leukemia and Lymphoma Society (LLS), raising $1.3 million USD since 2007.

 

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, gender identity or expression, 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.

 

Terumo Blood and Cell Technologies is committed to providing a safe, healthy and secure working environment. Our Colorado campus locations are tobacco-free workplaces, and we maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification.


Nearest Major Market: Denver

Job Segment: Testing, Quality Assurance, Medical Device, Substance Abuse, Behavioral Health, Technology, Healthcare

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