The Sr. Manager, Quality Operations, is responsible for interacting with all cross-functional teams to coordinate, execute, and maintain Quality System processes according to approved procedures in our medical device company. The Sr. Manager, Operations will support commercialization, efficiency, and growth by making recommendations to management and business leaders, especially related to Quality Operations, Purchasing Controls, Production/Process Controls, and Environmental Controls. The position may be required to perform all, or a combination of the following essential responsibilities as determined by necessity. This role is located at the Company’s Woburn, MA office.

Responsibilities:

· Ensuring and providing direction regarding proper implementation and oversight of Quality Operations and quality of the content including training, documentation and records

· Leading the implementation of company long range strategic QMS transformation initiatives

· Proactive planning and implementation of Quality strategic initiatives

· Establishing and providing change purchasing controls, production/process control systems including Inspection, Measurement and Test Systems as well as Environmental Monitoring with authors, process owners, and third parties in defining and producing lean Quality System Operations

· Establishing and managing proper Quality Operational specifically with P&PC and Supplier Quality review process

· Establish and maintain supplier controls working cross functionally with Supply Chain Management, R&D, and Suppliers.

· Establish and or enhance Supplier Control systems (process, audit, evaluation, and so on) that meet business needs and requirements.

· Establish monitoring and responding to metrics on the efficiency of the Supplier Quality and P&PC systems and its ability to support the business.

· Lead internal and external audits/inspections.

· Ensuring compliant and effective QMS are maintained in scope.

· Ensuring requirements are effective in processes in scope.

· Ensuring and providing direction regarding proper use of company incoming inspection, warehouse, NCMR, production/refurbishment, ESD, and Environmental controls. Partner closely with Quality Engineering Management, Manufacturing Engineering Management, and Operations Management for lean systems and compliance.

· Oversee product release to ensure that product is safe and effective for distribution.

· Provide direct support to Quality functions.

· Other duties as assigned.

· Bachelor’s degree in a scientific or technical field or equivalent experience.

· Preferred Quality Operations/Production Controls experience, 10+ years.

· 10+ years of experience in the Med/Device Industry, preferred

· Strong working knowledge of GMPs and other FDA regulations.

· Experience validating application activities.

· Solid Analytical skills – demonstrated ability to trouble shoot complex process/system issues.

· Experience in CAPA including root cause analysis, documenting findings/actions and implementing actions.

· Proven analytical capabilities.

· Excellent communication, organizational, and project management skills

· Successful experience working with cross functional teams across multiple work locations (third parties)

· Work cooperatively in a team environment.