Director of Quality - Production & Process Controls COE

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 proje