Manager, Quality Process Operations

Requisition ID:  34445  

 

At Terumo Blood and Cell Technologies, our 8,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world. For Terumo, for Everyone, Everywhere.

 

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. Advancing healthcare with heart.

 

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. Join us and help shape wherever we go next. You create your future and ours.

 

As a Manager, Quality - Process Operations, you'll lead a high-impact team driving excellence in medical device manufacturing. In this role, you’ll oversee line-side quality supervisors and technical experts, translating global regulations into actionable policies while championing compliance and continuous improvement. You’ll own critical Quality Management System processes—such as CAPA, complaint handling, audits, and post-market surveillance—while influencing organizational priorities and spearheading digital transformation initiatives. If you’re a proven leader with deep knowledge of FDA and ISO standards, and you thrive in a fast-paced, regulated environment, this is your opportunity to make a global impact on patient safety and product quality.

 

 

ESSENTIAL DUTIES

• QMS areas of ownership, management, and responsibility may include (as assigned): Non-conformance/ CAPA, Complaint Management, Audit support (internal, external, supplier), Post Market Surveillance (recalls / field actions, product risk review, post-market data review), Quality System Training, Document Control, Management Review, etc.
• Serves as expert and main point of contact for regulatory / compliance issues within area of responsibility.
• Acts as the policy / procedure owner for area(s) of responsibility, ensuring they are compliant and effective. 
• Executes their QMS area(s) in accordance with governing internal policies / procedures and external standards and regulations.  This likely includes:  data analysis, scheduling, approval of plans or reports, follow up on action items, facilitation of discussions with participants and stakeholders to ensure success and compliance.
• Monitors the health of the QMS areas(s) within their area of responsibility and provides metrics to management as required.
• Identifies and implements continuous improvement opportunities within their area(s) of responsibility, including emphasis on digital transformation efforts.
• Serves as Subject Matter Expert and Process Owner for their QMS area(s) of responsibility during audits and inspections.
• Influences the organization in quality objectives, prioritization and resourcing decisions as necessary.
• Manages team of direct reports in support of the above (as applicable).
• 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 compliance; may be the primary representative of Quality group on projects.
• During audits and inspections, interfaces with global regulatory authority, notified body auditors and provides general support for the Quality group.
• Interfaces with QMS area owners and project teams from other Terumo BCT locations, regions, and corporate.

 

 

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.

 

Experience

• Minimum 5 years experience.
• Preferred minimum 7 years experience in Quality Assurance and/ or Regulatory Affairs involving US FDA Class II or Cla