Operations Quality Administrator

Requisition ID:  33735  

At Terumo Blood and Cell Technologies, our 7,000+ 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 SUMMARY

Responsible for the coordination and control of quality-related documentation within the Operations Department. Key focus areas include managing document changes in Windchill, maintaining calibration and nonconformity records, and ensuring compliance with internal procedures and quality standards.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Document & Quality Systems Administration (Windchill)
  • Manage the document change control process in Windchill: initiate, monitor, and implement document revisions in coordination with stakeholders.
  • Maintain nonconformity records in Windchill, ensuring timely creation, follow-up, and closure.
  • Create and revise controlled documents (e.g., work instructions, procedures, forms) to support operations and ensure compliance.
  • Serve as the administrative point of contact for Windchill-related queries.
  • Ensure documentation complies with applicable regulations, quality system standards and internal procedures.
  • Participate in cross-functional meetings with departments including Quality, Supply Chain, Technical Support, and Service to coordinate documentation activities.
• Checklist Management
  • Maintain and control online checklist templates used across operations.
  • Coordinate updates to checklists, ensuring alignment with document change control protocols in Windchill.
• Calibration Coordination
  • Ensure equipment calibration activities are planned and executed on time.
  • Maintain calibration certificates and records for audit readiness and traceability.
• Compliance and Quality Support
  • Handle confidential documentation such as internal procedures with discretion.
  • Contribute to process improvement initiatives and support implementation of approved changes.
  • Support validation processes to ensure accuracy and compliance.
  • Support production planning as needed, collaborating with the Operations Bench & Manufacturing Manager and the logistics department.
  • Support documentation requests during audits and inspections by preparing and providing accurate records.
  • Provide training and support on any other additional task as assigned.

MINIMUM QUALIFICATION REQUIREMENTS

Education & Experience

Graduate degree or initial experience in an administrative role, with a solid understanding of document control processes.

Skills

• In line with Terumo BCT's Core competencies
  (Ensures Accountability, Collaborates, Customer Focus, Plans and Aligns, Instills Trust)
• Excellent didactic skills
• Very good oral and written communication skills in English and Dutch
• Good IT skills (Microsoft Office and Document control software)
• Relates well to a wide variety of cultures
• Requires the ability of self-management
• Good team player
• Work and collaborate effectively with all colleagues.
• Demonstrated accountability for administrative tasks, with eye for accuracy
• Demonstrated commitment to ongoing learning and professional development

ADDITIONAL INFORMATION

• Based: Terumo BCT Leuven office
• Reporting to: Operations Administration Team Lead

• 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