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 / email@example.com / 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.