Senior Manager, Operations Quality - Lakewood Factory

Terumo BCT, Inc.•Denver, CO

11d•Onsite

About The Position

The Senior Manager, Operations Quality – Lakewood Factory is a highly visible leadership role responsible for driving end‑to‑end product quality, regulatory compliance, and continuous improvement within a high‑volume medical device manufacturing environment. As the primary Quality Partner to the Plant Manager and a key member of the site leadership team, this role oversees operations quality, inspection and release, nonconformance management, calibration, supplier quality collaboration, and audit readiness. You’ll lead and develop cross‑functional quality teams, serve as the site subject matter expert during regulatory inspections, and champion Lean and Six Sigma–driven improvements that enhance efficiency, reduce risk, and elevate customer outcomes. This role is ideal for a strategic, hands‑on quality leader who thrives in regulated manufacturing, influences at the enterprise level, and is passionate about delivering the highest standards of product quality and compliance.

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.
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.
Knowledge of U.S. and international medical device regulations and standards (CFR 820, EU MDR, 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 members, 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.

Nice To Haves

AQL Certification
formal LEAN manufacturing training
Six Sigma desired

Responsibilities

Oversee Quality Engineers, Calibration department, Receiving Quality Assurance (RQA) through final Quality Control and release, with other Operations Quality functions as required.
Responsible for Operations Quality areas of ownership, management, and responsibility to 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 by using quality management techniques, such as LEAN Six Sigma, First Time Quality (FTQ) initiatives; identify and drive improvement Kaizen projects to either gain efficiency, eliminate out of the box failures, 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 existing on-market products.
Serves as expert and main point of contact for regulatory / compliance issues within area of responsibility. Partners with Sr Manager, TBCT Inc Legal Manufacturer to ensure overall QMS is inspection ready.
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 for Lakewood factory.
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.
During audits and inspections, interfaces with global regulatory authority, notified body auditors and provides general support for the Quality group.
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.
Interfaces with QMS area owners and project teams from other Terumo Blood and Cell Technologies (TBCT) locations, regions, and corporate.