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 resources.
• Support training and cross-training initiatives to enhance skill sets within the quality engineering team.

MINIMUM QUALIFICATION REQUIREMENTS

Education

• Bachelor of Science (BS) in Engineering (Mechanical Engineering, Biomedical Engineering, or related discipline).

Experience

• Minimum 10 years of experience in quality engineering, production quality, or manufacturing engineering in a regulated medical device environment.
• Strong background in ISO 13485, 21 CFR 820, CAPA, and validation processes.
• Experience managing nonconformance processes and leading root cause investigations.

• Proven track record in driving continuous improvement initiatives and process optimization.

Skills

• Strong leadership skills, with experience in mentoring and coaching engineers.
• Excellent project management skills, with the ability to handle multiple priorities effectively.
• Deep knowledge of root cause analysis methodologies (5 Whys, Fishbone, etc.).
• Strong analytical and data-driven decision-making skills.
• Proficiency in Power BI and other data analysis tools.
• Strong interpersonal and collaboration skills, with experience working in cross-functional teams.
• Ability to effectively communicate technical concepts to engineers, technicians, and senior leadership.
• Driver for acquiring resources and building consensus across teams.
• Solicits and accepts the ideas of others, as well as actively contributes to an environment conducive to open communication.
• Demonstrated ability to interact with regulatory agencies.
• Familiarity with sterilization processes, cleanroom environments, and associated product testing.
• Regularly and effectively presents complex technical information/analysis and responds to questions from technical staff members and management.
• Knowledge and use of relevant PC software applications and skills to use them effectively.

-Or-

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

LOCATION

Lakewood, Colorado - Onsite - Open to candidates willing to relocate to the area. 

TRAVEL 

Requires travel based on business needs.

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.

Target Pay Range:  $119,500.00 to $149,400.00  -  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.