Supervisor, Quality Assurance

Requisition ID:  31425  

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. 

This role will execute the strategic vision for the Quality Assurance of the production facility and drive systemic improvements related to quality, compliance, safety, efficiency, cost, and employee engagement.  As a supervisor, you will be responsible for oversight of highly technical operations, maintaining high quality and compliance expectations, and acting as the primary liaison to the quality organization.  You will also be responsible for supporting and achieving cross-functional alignment, team goals, and organizational goals.

ESSENTIAL DUTIES

• Lead a highly technical quality assurance team:
  • Lead, attend, and participate in quality metrics review meetings.
  • Build and maintain strong cross functional relationships to help drive quality/operational results.
  • Escalate issues requiring additional resources to quality leadership.
  • Proactively communicate relevant operational information with direct, cross-functional and plant leadership teams.
  • Lead technicians and conduct measurement and test of raw materials, in-process activities, and final acceptance.
• Meet Compliance Requirements:
  • Ensure the compliant execution of manufacturing activities
  • Ensure the compliant completion of manufacturing records and documentation
  • Initiate, segregate, investigate, and document nonconformances
  • Identify and investigate corrective and preventive actions (CAPA)
• Drive operational and quality excellence:
  • Leads and champions the pursuit of operational excellence for a production team. 
  • Possess a continuous improvement mindset and enthusiastic approach to problem solving.
  • Utilize Lean tools to improve operational performance including 6S, daily metrics, line balancing, process waste removal and standard work, etc.
  • Have a firm understanding of all relevant sources of process data, monitor trends, and coordinate with the appropriate resources to drive improvement.
  • Accountable for ensuring accurate data management and entry into relevant systems.
• Meet Cost Commitments:
  • Take ownership of your team’s performance against key metrics and ensure the team understands how they contribute to success daily. 
  • Provide input into annual budget process.
  • Ensure labor resources are aligned with the on-going manufacturing requirements. 
  • Monitor performance data daily and act/collaborate as necessary to ensure production targets are met.
  • Ensures operations schedules are met within budget through appropriate use of human and technology resources, scheduling and effective problem solving.
• Foster a culture of safety, accountability, and engagement
  • Possess the ability to coach and develop others to improve quality, production, and safety.
  • Foster a continuous improvement mindset amongst employees by proactively seeking input and feedback on manufacturing processes and procedures. 
  • In conjunction with employee development plans, provide opportunities for employees to participate on cross functional teams. 
  • Communicate effectively across multiple shifts and departments.
  • Ensure accountability of associates regarding training timeliness and adherence to company policies.
  • Manage team’s performance, including completing annual and mid-year reviews.
  • Maintain safety procedures and ensure production area is clean and organized. 
  • Ensure all safety incidents and observations are reported and documented appropriately.
  • Drive departmental safety culture by setting goals, monitoring key safety metrics, identifying trends, and implement improvements. 
  • Solicit feedback from employees regarding safety improvements on a regular basis. 

MINIMUM QUALIFICATION REQUIREMENTS

Education

• Bachelor’s degree, or equivalent of education and experience sufficient to successfully perform the essential functions of the job.

Experience

• Minimum 5 years’ experience in Quality role.
• Minimum of 3 years’ experience in medical device industry
• 2 years of leadership experience preferred. 
• Experience Quality Assurance operations environment preferred
• Exposure of Lean/Six Sigma practices preferred. 
• Experience managing in a regulatory environment preferred. 

Skills

• Demonstrated ability to lead and supervise associates.
• Requires ability to gain working knowledge of the products and their use.
• Knowledge of process automation preferred.
• Maintains working knowledge of quality management techniques and ability to develop quality and productivity goals and measures.
• Ability to learn, understand and apply statistical methodologies to manufacturing volumes.
• Knowledge of medical device regulations (ISO 13485 and 21CFR820)
• Knowledge of and experience executing basic problem-solving techniques
• Demonstrated ability to communicate effectively both verbally and in writing.
• Proven ability to lead and mentor others.
• Expert knowledge of regulatory and compliance guidelines and practices.
• Pro-active approach with strong problem-solving skills.
• Demonstrated knowledge of safety practices.
• 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.

PHYSICAL REQUIREMENTS

Manufacturing Environment requirements include: use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, and hand/finger dexterity.

• Must be able to work in a clean room environment, adhere to associated policies, and perform gowning of clean room attire in the allotted time prior to start up.
• Requires ability to move throughout the cleanroom and surrounding areas for the entire shift
• Requires ability to occasionally lift up to 20 pounds and transport up to 500 pounds via carts or mechanized equipment.
• Requires good manual dexterity and visual acuity.
• Must be able to work under florescent lighting.
• Requires the ability to sit or stand through the duration of a shift.

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:  $71,400.00 to $89,300.00  -  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:  7.0%

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.