Director of Design Control-Product Lifecycle Excellence

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Date: Jun 30, 2024

Location: Lakewood, CO, US

Company: Terumo BCT, Inc.

Requisition ID:  31909  

 

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. 

JOB TITLE: Director of Design Quality – Product Lifecycle Excellence

 

 

JOB SUMMARY

The Director of Design Quality – Product Lifecycle Excellence will direct all Quality Management System related activities for Research & Development, Risk Management, and Product Lifecycle Management.  As a member of the Global Quality leadership team, the Director will play an integral role in designing and implementing quality systems to support the successful development, release, and support all product lines, including both new product platforms and enhancements to existing products.  The Director will also drive the implementation and adoption of product lifecycle management and its appropriate integration with the Terumo BCT quality systems.

 

As the global design quality leader and subject matter expert for Global Quality Assurance, the incumbent works closely with cross-functional quality and organizational leaders, drawing out globally diverse thinking and idea generation, integrating best-in-class quality, design, and manufacturability perspectives along with front-line customer understanding to drive continuous state of audit readiness as well as ensuring quality at new product launches.  Provides inspirational guidance, bringing out the best in associates by instilling a bias for customer impact, data-driven results, commitment to excellence, and a collaborative, high-performing culture focused on continuous improvement and compliance.  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.

 

ESSENTIAL DUTIES

  • Provides strategic direction and operational leadership for design quality, risk management, and product lifecycle management efforts worldwide for Research and Development.
  • Provides significant influence on building quality into new product development to earn customer trust during new product launches. Exerts quality influence on corporate and objectives and long-range goals.
  • Accountable to drive organizational adoption for product lifecycle management tools by removing obstacles to the cross-functional teams.
  • Drives harmonization of global procedures and local procedures/work instructions to fully realize the value of One Quality System in the design quality, risk management among others.
  • Provides strong leadership to ensure a robust ‘culture of quality’ mindset is instituted in the business area.
  • Pursues the proactive development of new and existing business systems and processes beyond product quality management.
  • Works as a primary liaison with the R&D function to evolve product quality strategies and ensure process/system alignment including governance.
  • Ensures that the Quality Management System is established, implemented, and maintained for effectiveness in accordance with applicable standards (ISO 13485:2003, ISO 14971, MDD, CMDR, FDA Quality System Regulations).
  • Ensures that Risk Management requirements are met.
  • Directs Design Quality processes, systems, and projects to assure that all products designed meet customer, corporate, quality, and regulatory requirements.
  • Works with Engineering, Manufacturing, Regulatory, and Laboratory personnel to ensure compliance to Quality System design controls and proper documentation of the Design History File. 
  • Ensures internal and external audit actions are completed in a timely manner to maintain ISO certification and regulatory compliance.  Supports regulatory and notified body inspections and audits.
  • Ensures corrective actions and preventive actions are established, tracked, and trended, and that root cause elimination is completed for identified issues by appropriate function.
  • Ensures QA documentation is maintained and reviews-controlled documentation for quality and regulatory impact as required by regulatory agencies and internal stakeholders. 
  • Works with others to develop and implement effective training programs to achieve and maintain quality system and regulation awareness, ISO certifications, and Quality System compliance. 
  • Sets and reports appropriate Design Quality metrics to monitor and improve the performance of the Quality System.
  • Develops and implements a department organizational structure and associated budget that is efficient and effective in supporting the above activities.
  • Recruit, select, train, appraise performance, and administer salaries & bonuses of reporting employees; determines assignments and changes employees’ status in accordance with Terumo BCT policy.

 

MINIMUM QUALIFICATION REQUIREMENTS

 

Education

Technical degree and 10 years’ experience or equivalent combination of bachelor’s degree and experience.  Degree desirable in electrical or mechanical engineering, with design engineering experience preferred.

 

Experience

  • Minimum 10 years’ experience in Quality /Quality Control functions, with at least 5 years direct experience in the medical device manufacturing industry.
  • Experience in developing, managing, and auditing quality systems in a medical device environment.
  • Close involvement in more than one complete medical device product development cycle from concept through production and field service.
  • Experience over a wide range of product-based Quality activities, including design control, production quality, internal auditing, training management, and Corrective and Preventative Action (CAPA).
  • Experience in interfacing with FDA and/or other regulatory agencies, including preparing for and managing on-site external audits.
  • Experience at supervising and developing a Quality department/operation, including budgetary management, especially in a developing company.
  • Desirable: experience in a start-up or small company environment.
  • Desirable: experience establishing and growing a Quality department.
  • Desirable: experience at planning and leading an organization through ISO certification.
  • Desirable: experience dealing with quality management of both domestic and foreign suppliers.
  • Desirable: experience working with external vendors as part of an outsourced manufacturing system.
  • Desirable: experience with international standards related to medical design and manufacturing.

 

Skills

  • Must have expert knowledge in Design Controls Regulations and in Quality working within New Product Development
  • Proven ability to solve practical problems in a collaborative manner which yields effective compliance with QMS and external standards while allowing for the use of efficient and flexible implementation approaches. 
  • Proven ability to interact with senior management team, including influencing other members in matters of significance to the organization.
  • Demonstrated ability to organize and motivate cross-functional and multi-facility teams to meet quality goals. Ability to communicate and work effectively as a team member and colleague within functional team processes such as CAPA and design reviews.
  • Possesses a strong drive to seek and solve existing or latent problems. Maintains a consistent and resolute willingness to take ownership and accept responsibility for actions and decisions.
  • Capability to interact with diplomacy and tact to senior management, employees and customers while maintaining appropriate assertiveness and persistence.
  • Excellent written and oral communication skills and a proven ability to communicate effectively.  Proven ability to read and interpret documents of significant complexity, including external standards, design inputs, verification/validation protocols, and clinical studies.
  • Expertise in Microsoft Office applications such as Word, Excel, Access, and Visio are required.

 

-Or-

 

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

 

Additional Requirements

  • There will be occasional requirement to work outside of normal business hours, consistent with other Director-level positions.
  • Some international travel will be required (20 - 25%)

 

PHYSICAL REQUIREMENTS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

In the typical office environment requirements include reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.

 

 

 

 

Target Pay Range:  $183,200.00 to $229,000.00  -  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: PLM, Medical Device, Quality Assurance, R&D Engineer, CAPA, Management, Healthcare, Technology, Engineering

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