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Manual SQA (NS)

Company: Kforce Technology
Location: Miramar
Posted on: September 14, 2023

Job Description:

Kforce has a client seeking a Manual SQA in Miramar, FL.

Summary:
The Manual SQA ensures site activities associated with medical device manufacturing and testing comply with quality management systems and applicable regulatory requirements. The candidate coordinates Quality Management Systems ensuring compliance to all relevant regulations and standards including FDA QSR Part 820; including change management, record retention, training, and assist with the internal audit program.

Essential Functions:
The list of essential functions, as outlined herein, is intended to representative of the duties and responsibilities performed within this classification. It is not necessarily descriptive of any one position in the class. The omission of an essential function does not preclude management from assigning duties not listed herein if such functions are a logical assignment to the position.

Duties Include:

  • Manual SQA organizes documents for management review, software release, and audits
  • Creates and monitors reports for departmental key performance indicators, tracks and trends
  • Administers the document control system including monitoring, cataloging and reporting on the status and stages of various documents
  • Manages the medical device complaint process including documentation and fielding of issues to the appropriate parties for investigation and resolution
  • Manual SQA coordinates quality and regulatory compliance training programs for the department
  • Promotes culture of quality and mentors cross-functional teams
  • Provides support to the supplier management process
  • Provides administrative support to all Information Technology departments as required

Keywords: Kforce Technology, Hollywood , Manual SQA (NS), Other , Miramar, Florida

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