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Date: Jul 8, 2024

Location: Littleton, CO, US

Company: Terumo BCT, Inc.

Requisition ID:  31659  

 

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 Director of Quality – Littleton factory will lead all quality-related teams and activities to drive product quality improvement efforts, acts as a member of factory leadership team, support and drive factory-level projects and efficiencies, and ensure on-going conformance to established applicable standards, regulations and agency guidelines.

 

This leader will oversee all quality aspects of Terumo BCT’s Littleton, CO, manufacturing facility supporting our Plasma Innovations business. This factory has a highly automated manufacturing process for disposable medical devices and this quality leader will oversee a variety of ramp-up activities including hiring strong talent, efficient process development, development and execution of critical validation strategies, among other duties. This role presents an unique opportunity to shape the quality organization that will be at the forefront of supporting the highest volume factory in the Terumo BCT global network within a year.  This leader develops and maintains exceptional internal and external relationships with stakeholders and regularly monitors the external landscape as it relates to the Company’s long-term business objectives.  Ensures all quality activities are in accordance with applicable laws, rules and regulations of the intended markets meeting the highest quality standards and customer expectations.  This role is accountable to the outgoing product quality and in maintaining the integrity of QMS.

 

ESSENTIAL DUTIES

 

Lead Factory Ramp Up and Efficient Production Processes:

  • Supports factory ramp by filling critical headcount with experienced and talented team members in a timely manner.
  • Leads site validation activities related to initiating new lines and process improvements.
  • Directs supplier quality and receiving quality assurance resources and processes to ensure tooling/equipment validations support factory production volume commitments and that non conformances are addressed in a timely manner without impact to material supply.
  • Drives clarity on product specification by partnering with R&D to ensure product and material specifications meet customer needs, and support manufacturability.
  • Identifies the gaps and strengthens QMS where needed, including identifying procedures and policies that put product supply at risk and revamp to ensure high quality and product supply requirements are met.
  • Partners effectively with site operational excellence leader to develop daily metrics and operating mechanisms to drive continuous improvement of NC/CAPA processes, validation, defect frequency, and other critical to quality and supply metrics.

 

Drives Improvements to Product Quality:

  • Maintains strong GEMBA orientation and drives culture of accountability and continuous improvement mindset.
  • Understands customer issues and works to resolve problems with product, procedures and policies, driving significant change to process or system where necessary to resolve these issues.
  • Interfaces with site and global teams to support product complaint investigations and actions, NCs or CAPAs to ensure product conformity as well as support global changes to drive down complaints.
  • Ensures adequate root-cause investigation and resolution of issues to avoid repeat or inadequate resolution of product quality issues.

 

Facilitation and Relations:

  • Develops/maintains constructive relationships with customers, operations, and other business/regional/functional entities served and ensure such relationships exist throughout the organization.
  • Simplify problems and develop solutions that eliminate issues and improve relationships across all functions and processes in Terumo BCT.
  • Facilitates the sharing of best practices across the company.
  • Works with internal and/or external resources to resolve problems of exceptional complexity and sensitivity. May be primary representative of operations or quality group on projects or management teams.
  • Works with global and external resources to manage all areas of responsibilities including Operations, R&D, etc.

 

QMS Compliance:

  • Demonstrates knowledge and skills of QMS/cGMP requirements including medical device and combination products.
  • Implements QMS to support certification by regulatory bodies.
  • Develops and reports and improves on metrics related to QMS.
  • Ensures audit and inspection readiness at all times.
  • Responsibilities include influencing and driving teams in the areas of process improvements, trend monitoring and correlating leading quality metrics, problem solving approaches, and data analysis. Leads root cause analysis of complex systems issues.
  • Evaluates changes to products ensuring that the implications of changes are fully understood.
  • Leads Management Review for factory that drives active cross-functional involvement and continuous improvement.
  • Constantly analyzes changing business and customer needs and propose organizational or systems changes to address these needs. Recommends changes to other areas that will improve overall effectiveness.

 

Process and Systems:

  • Responsibilities include factory complaint investigation processes, internal audit processes, and CAPA processes. Works with manufacturing, engineering, and other functional groups on regulatory compliance issues. Develops or participates in the development of solutions to problems of moderate to high complexity. Interprets, executes and recommends modifications to operating policies where appropriate.
  • Serves as Management Representative for FDA responsibilities and holds plant manager accountable for role as Management Respresentive with Executive Responsibility.

 

People Management and Team Development:

  • Leads a culture that reflects Terumo Core Values and quality principles. Accountable for continuous development of associates toward expectations.
  • Ensures effective formal training and development of professional skills and behaviors for associates.
  • Promotes associates development through participation on cross-functional teams.
  • Directs the development and management of budget for areas of responsibility.
  • Recruits, selects, trains, appraise performance, and administer salaries of reporting employees; determines assignments and changes employees’ status in accordance with Terumo BCT policy.

 

Business Processes:

  • Ensures that activities are managed in accordance with Terumo BCT Code of Conduct and appropriate business controls.
  • Understands business process issues and priorities, and manages resources effectively to resolve problems in the processes, procedures and policies, driving change (systems, tools, training processes, and procedures) where necessary to meet customer and business needs.
  • Influences short and long term business goals and operating policy. Exerts influence on corporate objectives and long-range goals in areas related to QMS and compliance.
  • Support factory ramp by filling critical headcount in a timely manner.

 

MINIMUM QUALIFICATION REQUIREMENTS

 

Education

Bachelors degree in Quality or STEM-related discipline with 10+ years experience, and 5 years management experience, or a Masters Degree in a related discipline.

 

Knowldege and Experience

  • 10 years experience and 5 year management experience, or an equivalent combination of education and experience.
  • 5+ years experience in a manufacturing environment with highly/fully automated manufacturing processes, preferably in the medical device industry.
  • Demonstrated QMS and audit expertise for Medical Device and Combination products and knowledge of applicable standards (including but not limited to ISO 13485, ISO 14971, MDD, CMDR, FDA Quality System Regulations).
  • Extensive knowledge of U.S. and international medical device regulations and standards.
  • Requires understanding of quality management requirements and experience in developing quality goals and measures and directing others, including R&D, suppliers, and process engineering.

 

Skills

  • Demonstrated skills in leadership and development of people and teams. Capability to build and maintain effective working relationships across functions and organizations and levels.
  • Demonstrated expertise in planning, budgeting, personnel development, and project management directed toward achievement of both short- and long- term business plans and goals.
  • Demonstrated knowledge and application of manufacturing protocols, statistical tools and methodology, and continuous improvement techniques.
  • Demonstrated effectiveness with interpersonal skills and the ability to interface with Senior Management, internally and externally and the ability to interact with diplomacy and tact while maintaining appropriate assertiveness and persistence.
  • Demonstrates a positive, direct, proactive approach to problem solving and impediments, mentors others to understand and model this approach. Constructive and relentless in pursuit of solutions. Motivates others to do the same.
  • Ability and success to routinely diagnose problems and recommend solutions through teamwork, failure mode analysis and other analytical techniques.
  • Thorough understanding of measures of customer satisfaction and experience in their implementation as a tool for continuous improvement.
  • Cultural and situational flexibility and adaptability is essential.

 

LOCATION

Littleton, Colorado

 

PHYSICAL REQUIREMENTS

Typical Office Environment requirements include: reading, speaking, hearing, close vision, traverse, bending, sitting, and occasional lifting up to 20 pounds.

 

Additional Physical Requirements

Travel, including internationally, will be required at < 15%.

 

Target Pay Range:  $177,400.00 to $221,700.00  -  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:  30.0%

 

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.


Nearest Major Market: Denver

Job Segment: Medical Device, Substance Abuse, Behavioral Health, CAPA, Quality Assurance, Healthcare, Management, Technology

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