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QA Documentation Specialist

Job Title: QA Documentation Specialist
Contract Type: Permanent
Location: Midlands
Industry:
REF: 122470
Contact Name: John Reid
Contact Email: johnr@rftgroup.ie
Job Published: over 1 year ago

Job Description

QA Documentation Specialist

Due to continued expansion of their operations our client a well-established Multinational Healthcare Manufacturer now require a qualified and experienced QA Documentation Specialist.

This is a permanent role based in The Midlands with good advancement possibilities.

Key Responsibilities of QA Documentation Specialist
  • Work as part of the complaints investigation team.
  • Customer Complaint investigations including DHR (Device History Record) review, Failure Analysis reports, and Risk Management review.
  • Trending of Complaint data and reporting to Management.
  • Documentation management, including distribution and filing of all documents associated with medical devices.
  • Processing of Change Request Notes
  • Routing of controlled documents through the approval process.
  • Issue and maintenance of controlled documentation.
  • Carry out other tasks or responsibilities as directed by the QA manager.

Requirements of the QA Documentation Specialist
? 3rd Level Diploma or Degree qualification in an Engineering or Science discipline.
  • Minimum of 2 years? experience working within a QA function in an FDA or ISO 13485 regulated Industry.
  • Demonstrated understanding of criticality of attention to detail, data accuracy and document control
  • Must have the ability to communicate effectively with management and fellow peers

Please send an up to date CV and cover letter to John Reid at The RFT Group / johnr@rftgroup.ie / on 01-2302400 / www.rftgroup.ie

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The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.