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Job Details

QA/RA Engineer

Company: Hobson Prior
Location: New South Wales
Reference: DE475657
Closing Date: 14 Mar 18
Type: Permanent
Salary (£): On Application
Benefits: £80,000 - £95,000

Job Summary:

My client is an early stage and start-up medical device company that are innovative and leading the way in diagnostics. They are going through a period of rapid growth and new product launches and require a QA/RA Engineer to assist them with ongoing compliance and regulatory approvals. 

Requirements:

My client is an early stage and start-up medical device company that are innovative and leading the way in diagnostics. They are going through a period of rapid growth and new product launches and require a QA/RA Engineer to assist them with ongoing compliance and regulatory approvals. 

Role / Responsibilities : 

  • Implementing and maintaining QMS to ISO13485 standards
  • Preparation of technical files for Regulatory Submissions
  • Give Quality and Regulatory advice on the design and manufacturing of devices
  • Perform Internal audits and handle external audits.

Skills Experience :

  • Experience of GMP and process improvements
  • ISO14971 and risk management experience would be desirable 
  • Experience of customer complaints would be desirable 
  • Experience of working with FDA/TGA/EU notified bodies & standards

 

If you feel you have the right skills and experience for the role then please apply now, for a confidential discussion about this role or your career options then please call (02) 9965 9490 or email daniel.evans@hobsonprior.com.au

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Contact Information:

Address:  Hobson Prior International Ltd
Wellington Gate
7-9 Church Rd.
Tunbridge Wells
kent
TN1 1HT
England
Tel:  01892 612 612
Fax:  01892 612 613
Website:  Visit Our Web Site

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