Leads specified Quality Team supervising overall execution to quality process at the manufacturing facility. The Sr. Quality Manager 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.
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 through the use of 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.
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 areas(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.
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
Bachelor’s degree in Engineering or a Scientific field and experience sufficient to successfully perform the essential functions of the job may be considered.
Formal LEAN manufacturing training and/or Six Sigma desired.
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
ASQ experience (certification)
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
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.
An equivalent competency level acquired through a variation of these qualifications may be considered.
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.
Internal Number: 24623
Terumo BCT, a global leader in blood component and cellular technologies, is the only company with the unique combination of apheresis collections, manual and automated whole blood processing, and pathogen reduction coupled with leading technologies in therapeutic apheresis and cell processing. We believe in the potential of blood to do even more for patients than it does today. This belief inspires our innovation and strengthens our collaboration with customers.
As we strive to make even safer, higher-quality transfusions available to more people, we can unlock the potential of blood and cell therapies. We can help our customers bring even more treatment options to patients through advanced blood therapies. We can support researchers in developing cellular therapies that may fundamentally improve health care. Terumo BCT is guided by our customers' needs, aspirations and ongoing drive to improve efficiency and patient outcomes.
Unlocking the Potential of Blood.
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