Medical Device Quality Systems Specialist

Providence, RI

Industry: Medical Device Job Number: 147353

 

Medical Device Quality Systems Specialist

Our client  is an ISO 13485 certified and FDA registered full-service product development firm. They have an exclusive focus on medical products and over 25 years of experience developing medical devices, in vitro diagnostic (IVD) products, combination products, and consumer healthcare products. They help develop class I, II, and III products. 

The Quality Systems Specialist provides company leadership in the maintenance and improvement of corporate-wide quality management systems and support processes. S/he proactively manages the various elements of the quality system to ensure compliance to applicable national and international quality system regulations.

Responsibilities:
  • Support the Quality Systems Manager to provide hands-on ownership for the various elements of the Quality Management System including corrective and preventive action (CAPA), customer complaints, and/or internal audits etc. to ensure successful performance during third-party audits.
  • Ownership of CAPAs, customer complaints, audit findings, and/or internal audits.
  • Compile and track appropriate metrics and data to demonstrate Quality Management System compliance
  • Review and approve Internal and External audit reports, as well as, any audit findings.
  • Perform Risk Assessments for quality observations.
  • Ability to perform Quality System Software Validations, as needed.

Job Type: Contract 

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