Interim Quality Manager

Carlsbad, CA

Job ID: 127453 Industry: Med

 

Interim Quality Manager

Environment:
Our client a large medical device company that manufacturers class 2 products.They are in the midst of transferring production to another site and winding down the existing one. They are looking for a Quality Manager to support these activities for the next 2 years. 

Project Scope &  Responsibilities:

The Interim Quality Manager is needed to manage a team of highly functional quality engineers. The position supports CAPA, DHF, new quality system/methodologies implementation, training, and problem solving. This position will also work directly with North American Quality, Regional Functions and Departments, and External Suppliers to provide sustaining quality and compliance leadership in the specific areas related to CAPA and DHF, training and problem solving. In addition, the position is responsible for reporting key quality metrics to drive quality and efficiency.

This individual should have hands-on management of a small team of quality engineers and work collaboratively with key stakeholders in the planning, execution and reporting to corporate of NonConformances & CAPAs. They will lead CAPAs independently (and as the team leader) from planning through to execution, closure, reporting and follow-up. They will assist in the review of site CAPAs for retrospective reviews to ensure compliance to quality system requirements. This individual will be interfacing with Division RAQA Heads, Quality Management and to assure alignment to the Global Quality System. They will formulate, write and maintain procedures, specifications and standards for the quality control of products including non-destructive testing methods, gauge design and procurement, sampling and inspection methods and visual acceptance standards. Strong knowledge in 21 CFR 820, 11, 806 and ISO 13485 required.

Required:
  • Medical Device Experience 10 years
  • Management or Project Management experience
  • Quality Systems
  • ISO 13485

Desired:
  • Orthopedic Products

Job Type: Contract

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