Senior Manager, Operations Quality - Lakewood Factory

Senior Manager, Operations Quality – Lakewood Factory

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.

• 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; demonstrate 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 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…