Manager, Production Quality Engineering

Requisition ID:  33463  

 

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. 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.

The Production Quality Engineering Manager will lead and manage a team of Production Quality Engineers in a Class II FDA-regulated medical device manufacturing environment. This role is responsible for ensuring compliance with ISO 13485 and 21 CFR 820, driving quality improvements in manufacturing, and managing validation activities. The manager will serve as a key technical contact for the organization, collaborating with cross-functional teams and interfacing with senior-level engineers and technicians on technical matters. This individual will be accountable for nonconformance management, corrective and preventive actions (CAPA), validation, data analysis and continuous process improvement.

 

The Production Quality Engineering Manager will serve as the subject matter expert (SME) for Production Quality and validations and will own the ongoing maintenance, execution, and continuous improvement of the Quality Management System (QMS) for their area.

 

ESSENTIAL DUTIES

Leadership & Team Management:

• Manage and provide leadership for the Production Quality Engineering team, ensuring team development, effectiveness, and direction.
• Coach, train, and develop engineers to enhance problem-solving and technical expertise.
• Drive accountability and performance within the team, ensuring alignment with organizational objectives.

Quality & Compliance Management:

• Ensure compliance with ISO 13485, 21 CFR 820, and company quality policies.
• Manage the nonconformance process, ensuring thorough investigation, timely record completion, and driving nonconformance reduction.
• Oversee CAPA activities, ensuring robust root cause analysis (e.g., 5 Whys, Fishbone Diagrams) and driving corrective and preventive actions to closure.
• Support internal and external audits, providing documentation and implementing corrective actions as needed.

Manufacturing Support & Process Improvement:

• Collaborate with manufacturing, process engineering, and validation teams to drive quality improvements.
• Evaluate and approve proposed solutions, modifications, and process adaptations to maintain product quality.
• Lead process improvement initiatives using data analytics, Lean, Six Sigma, and other quality methodologies.
• Develop, maintain, and monitor KPIs for quality and manufacturing performance.
• Act as an internal champion for quality, ensuring production processes are optimized for compliance and efficiency.

Technical Expertise & Validation:

• Provide technical guidance in validation, process control, and risk management for manufacturing operations.
• Ensure production validation activities, including IQ/OQ/PQ, are effectively executed and maintained.
• Represent the Quality organization as the main technical contact for projects, interfacing with senior engineers, technicians, and cross-functional teams.

Strategic & Business Responsibilities:

• Participate in annual budgeting processes for the team, ensuring proper allocation of resource