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Biomedical Search Consultants
Published
November 22, 2024
Location
Fitchburg, MA
Category
Default  
Job Type

Description

Our client, a contract manufacturer for the medical device, defense, and life science markets, has an immediate opening for a Quality Systems Manager. This role will oversee daily document control activities and actively participate in the Internal Auditing program as a primary internal auditor.

Responsibilities:

  • Assist in the quality system training for new employees and provide support to other departments for training on changes
  • Assure all document control changes are properly communicated, distributed, and controlled
  • Collaborate with associated departments in support of process improvement/enhancement activities
  • Compile certification documents, perform final packaging/labeling audit, and release product for shipment
  • Coordinate document change activity and process changes to prints, procedures, and forms in accordance with established practices and standards
  • Liaison with regulatory reporting agencies and environmental consultants
  • Monitor applicable quality systems through trending analysis, compiling metrics, and developing reports on a regular basis
  • Perform and document customer complaint investigations and assist Quality Manager with findings to assure actions are effective
  • Other responsibilities as required

Requirements:

  • 10+ years of similar work experience
  • Bachelor of Science degree preferred
  • Ability to read and interpret engineering drawings
  • Detailed understanding of regulatory and compliance protocols for ISO 13485 and cGMP 21 CFR part 820
  • Must be able to read, write, and speak English fluently
  • Must be capable of developing procedures, work instructions, flow charts, and forms in support of the quality system requirements
  • Strong facilitation, communication, and training skills
  • Proficiency in the use of computers, specifically the programs associated with Microsoft Office
  • Experience with IQMS ERP is a plus
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