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Director of Quality

2 months ago

Lakewood, United States Terumo BCT Full time

Press Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: Director of Quality - Production & Process Controls COE

Location:

Lakewood, US Requisition ID:

32378 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. JOB TITLE:

Director of Quality – Production & Process Controls COE JOB

SUMMARY This role is responsible for production & process controls center of excellence. Leads specified Quality Team supervising overall execution to quality process at the manufacturing facility and production & process controls center of excellence. The Director of Quality will play an integral role in ensuring the ability to produce a high-quality product, processes are aligned with regulations and standards which are aligned efficiently and compliantly with Terumo BCT policies and procedures, and owning the ongoing continuous improvement, maintenance, execution, of QMS area(s) of responsibility. This role has responsibility for Product Quality support through all phases of production and be expected to participate fully as part of the manufacturing leadership team to ensure we meet customer expectations of the highest quality product conforming to all required regulations. As the production & process controls leader and subject matter expert, 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 quality improvement at each site. Develops and communicates a strategy for the production and process controls quality and leads highly capable, empowered site teams to translate into operational plans. 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. 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 Standardize the RQA processes across all the TBCT Inc affiliated entities and create a center of excellence. Drives clarity on product specifications by partnering with R&D to ensure product and material specifications meet customer needs, and support manufacturability. Oversee Quality Engineers, Calibration department, Receiving Quality Assurance (RQA) through final Quality Control and release, with other Operations Quality functions as required. Operations Quality areas of ownership, management, and responsibility may include (as assigned): Incoming product testing, QC in-process testing, Product Quality and Continuous Improvement, Production and Process Controls, Non- conformance investigation and controls, Product Release, Supplier management, CAPA, Audit (internal, external, supplier), Quality System Training, Document Control, Management Review, etc. Understand & Support medical device and high -volume

disposables manufacturing; demonstrated ability to improve product and process quality using quality management techniques, such as LEAN Six Sigma, First Time Quality (FTQ) initiatives; identify and drive improvement Kaizen projects to either gain efficiency, improve product quality or cost down. 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 issue. Oversee and manage Non-conformance (NC) process and root cause investigation. Work with cross functional team to drive improvements to systemically reduce causes of NCs or other forms of variation. Oversee and manage the throughput and backlog of inventory in incoming and final inspections, and staff/schedule

accordingly. Oversee and manage calibration and maintenance of all equipment and tooling in the site, facilities, custom tooling at applicable suppliers, and custom service equipment worldwide. Staff/schedule accordingly. Partner with Supplier Quality function to monitor and manage quality across supply chain to ensure high quality production for either new product development or older products. Serves as expert and main point of contact for regulatory / compliance issues within area of

responsibility. Owns and Executes their QMS area(s) in accordance with governing internal policies / procedures and external standards and regulations to ensure efficiency and compliance. This likely includes generation and approval of annual schedules, execution to schedule, approval of plans or reports, follow up on action items, facilitation of discussions with participants and stakeholders to ensure success and compliance. Monitors the Product Quality & Compliance health of the

QMS a reas(s) within their area of responsibility, and provides metrics to management as required, including any governing oversight boards. Identifies and implements continuous improvement opportunities within their area(s) of

responsibility. Serves as Subject Matter Expert and Process Owner for their QMS area(s) of responsibility during audits and

inspections. Influences the organization in quality objectives, prioritization, and resourcing decisions as

necessary. Manages and provides operational leadership for the functional group’s development, direction, and

effectiveness,

adhering to organizational policies and processes and supporting overall business and corporate

objectives. Acts as an internal champion for quality initiatives aimed at improving business systems and compliance; may be the primary representative of Quality group on projects. Maintains strong GEMBA orientation and drives culture of accountability and continuous improvement mindset. During audits and inspections, interfaces with global regulatory authority, notified body auditors and provides general support for the Quality group. Interfaces with QMS area owners and project teams from other Terumo BCT locations, regions, and

corporate. MINIMUM QUALIFICATION

REQUIREMENTS

Education

Bachelor’s degree in Engineering or a Scientific field and experience sufficient to successfully perform the essential functions of the job may be considered. AQL Certification, formal LEAN manufacturing training and/or Six Sigma

desired. Experience Minimum 10 years

experience. Preferred minimum 7 years experience in Quality Assurance with a heavy emphasis on factory operations, QC testing, product release and nonconformance management. Minimum 5 years supervisory

experience. Preferred training in FDA Quality System Regulation and ISO

13485. Experienced in high volume automated assembly of medical

devices. Experienced in leading audit responses to various notified

bodies. Prior experience in manufacturing/operations quality role with leading and overseeing group of

engineers Excellent leadership skills, ability to identify and hire talent to support the business

needs Good communication and presentation skills, especially with higher management on business-critical

initiatives Skills Knowledge of U.S. and international medical device regulations and standards (CFR 820, MDD and ISO

13485). Strong interactive skills in cross functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross functional team member, team behavior, and support for subordinates, quality specialists, and management. Scientific problem-solving skills using industry accepted tools such as DMAIC, KT Analysis, or

equivalent. Solicits and accepts the ideas of others, as well as actively contributes to an environment conducive to open

communication. Capability to interact with diplomacy and tact while maintaining appropriate

assertiveness. Demonstrated ability to communicate effectively both verbally and in

writing. Knowledge and use of relevant PC software applications and skills to use them

effectively. Must be detail oriented, well organized and able to work independently and in

teams. Demonstrated ability to lead people and get results through

others. -

Or- An equivalent competency level acquired through a variation of these qualifications may be

considered. PHYSICAL

REQUIREMENTS Typical Office Environment requirements: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds. 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. Additional Physical

Requirements Requires travel based on business

needs. Target Pay Range:

$89.00 to $111.00 - Hourly pay rate 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:

Los Angeles Job Segment:

Medical Device, Lean Six Sigma, Testing, Six Sigma, Industrial, Healthcare, Management, Technology, Manufacturing

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