Commercial Quality Site Lead

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Job Function:

Quality

Job Sub Function:

Customer/Commercial Quality

Job Category:

Professional

All Job Posting Locations:

Bridgewater, Massachusetts, United States of America

Job Description:

Overall purpose of job:

The Commercial Quality Site Lead is responsible for the oversight and execution of Quality and Compliance (Q&C) programs at the Value Added Service Center (VASC) located in Bridgewater, MA.

 

This position serves as a liaison with Quality and Supply Chain partners, and the MedTech DELIVER team on field returns quality related matters and collaborates with the DePuy Synthes and MedTech DELIVER NA organizations to drive timely resolution of quality related issues. This position identifies and supports implementation of improvement opportunities consistent with DELIVER NA business objectives and the Enterprise Quality Standards.

 

This position is accountable for development, execution and oversight of quality and compliance programs designed to meet customer and business needs in compliance with regulatory requirements and the Quality Management System.

Key responsibilities:

• Responsible for quality & compliance oversight of the Value Added Services operations at the site including Returns, Set Assembly, Torque Testing, Donations, etc.

•  Responsible for the management of all internal (ERC) and external Health Authority inspections (e.g. FDA, TUV/BSI) conducted at the site, including reviewing the preparation plan with on-site management.

•  Ensure returned product is dispositioned according to predefined agreements with Operating Company, Franchise, or Marketing Company.

•  Define and implement quality requirements and systems in alignment with department strategy.

•  Support execution of the Quality System for the site.

•  Ensure the Quality program maintains regulatory compliance.

•  Support cross-functional teams to identify, investigate, document and correct quality issues related to the field returns process.

•  Provide quality support for technology transfer and improvement of existing distribution processes including ensuring change control requirements are met.

•  Support development of and review and approve standard operating procedures.

•  Support registration maintenance for the site, as the need arises.

•  Facilitate, coordinate and assist in Supplier Audits, when applicable.

•  Make proposals and assist in the development of corrective action plans and monitor implementation including follow-up on closure and metric reporting of CAPA, NC, and audit observations, as applicable.

•  Establish and maintain relationships with NA DELIVER & Franchise customers in order to solve problems and meet changing competitive and regulatory environments.

•  Coach and mentor Deliver business partners in the areas of root cause analysis, ISO and cGMP requirements as needed.

•  Performs other related duties as required.

Required Qualification and Core Competencies for the role:

EDUCATION:

A Bachelor's or equivalent University degree is required, with a focus in science, engineering, technology or math preferred.

  

EXPERIENCE AND SKILLS:

 

REQUIRED:

• 5-7 years of relevant experience in regulated healthcare industry.

•  Knowledge of FDA 21 CFR Part 820 and/or ISO 9001 and/or ISO 13485

•  Business experience in regulated industry in a fast paced, dynamic, global operation.

•  Ability to develop and administer a strategic audit plan that optimizes compliance an