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Manager, Production Quality Engineering

3 months ago

Lakewood, United States Terumo BCT Full time

Requisition ID: 31924

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.

The Production Quality Engineering Manager will oversee and provide leadership for the Production Quality Engineering, Validation, and In-process testing teams. This role is integral in driving quality improvements in manufacturing, maintaining compliance to standards and regulations, and ensuring product testing is completed in timely and consistent manner. The Production Quality Engineering Manager will be the subject matter expert for these areas and will own the ongoing maintenance, execution, and improvement of the QMS for these areas.

ESSENTIAL DUTIES

  • Manages and provides leadership for the team's development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.
  • Responsible for identifying and implementing projects and initiatives to reduce defects, improve product quality, and streamline quality processes.
  • Manages the Nonconformance process to ensure the appropriate investigation of issues, timeliness of record completion, and drives a reduction in the number of nonconformances generated.
  • Collaborates with production, process engineering, R&D, and contract manufacturers as appropriate to ensure changes and nonconformances are handled appropriately.
  • Actively participates in the annual budgeting process and is responsible for managing an operation within budgetary guidelines.
  • Develops, maintains, and monitors KPIs for areas of responsibility.
  • Analyzes quality data for trends and presents this analysis to the management team.
  • Understands and implements FDA or other regulatory requirements as necessary.
  • Serves as expert and main point of contact for regulatory/compliance issues within areas of responsibility, including serving as Subject Matter Expert for areas of responsibility during audits and inspections.
  • Manage, continuously improve, and provide oversight for validation processes, in-process testing, and quality engineering processes.
  • Plans, guides, and reviews projects and work from the team to ensure that the desired outcome is achieved.
  • Utilizes technical skills to evaluate proposed solutions, adaptations, and modifications to projects.
  • Acts as an internal champion for quality initiatives aimed at improving business systems and compliance; may be the primary representative for Quality on projects.
  • Interfaces with Quality Engineering and project teams from other Terumo BCT locations and regions.

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.
  • Bachelor of Science Degree in Engineering, preferred.

Experience

Minimum 10 years experience.

Skills

  • Strong leadership capabilities to ensure continuous guidance, coaching, and directing teams to success in their tasks and professional development.
  • Strong project management, problem-solving, resource management skills.
  • Demonstrated skills in developing, coaching, and training others in an organizational setting.
  • Excellent in collaboration in working with cross-functional groups.
  • Stronginteractive skills in cross functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross functional team members, team behavior, and support for subordinates, junior engineers, technicians, and management.
  • Represents the organization as the main technical contact on projects. Interacts with senior level associates on significant technical matters often requiring coordination between organizations.
  • 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.
  • In-depth knowledge of ISO 13485 and 21CFR820 requirements.
  • 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.
  • Demonstrated ability to communicate effectively both verbally and in writing.
  • 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 - Open to candidates to 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:$121,200.00to$151,500.00 -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.