Quality Assurance Officer

17 Mar 2017
14 Apr 2017
Contract Type
Full Time



£Excellent DOE


We are looking to appoint a Quality Engineer, preferably from a medical or pharmaceutical background, for our client who specialises in the manufacture of gas monitoring and delivery instruments for medical markets throughout the world. Reporting directly to the Quality Assurance Manager the prime role of the QA Engineer will be the sampling, assessing and verifying of products to meet ISO 134845 quality standards and regulatory standards applicable to meet the company's MET mark / FDA requirements. In addition, you will support legal compliance and customer expectations, as well as adding support to the development of technical documentation to meet, and maintain, quality standards of manufactured medical devises.

Key Responsibilities:

  • Assist in management of product specifications, including evaluating company's product specifications in line with customer requirements
  • Set objectives for quality assurance compliance to achieve required targets
  • Plan and implement performance improvement and quality assurance programs
  • Ensure product compliance with legal, regulatory and quality standards
  • Develop procedures that ensure regulatory compliance for medical device adverse event reporting
  • Guide production staff regarding quality measures
  • Understand, assess and perform tests required to investigate product modifications and improvements
  • Determine quality related training requirements, implementing training where required
  • Assist in completion of CAPA, Complaints and Non-Conformities
  • Carry out Internal Audit activities


Key Skills:


  • Good organisational, planning and problem solving skills
  • Good interpersonal and communication skills
  • Ability to work as part of a team with ability to motivate and influence
  • Proven experience in a similar QA role
  • Medical device regulatory experience (ISO13485 and 21 CFR Part 820) is desirable


Company benefits include 25 days holiday, plus bank holidays, Company pension scheme (membership available immediately), Private medical insurance cover (after 6 months service), Life assurance, option to work 4.5 days per week (early finish on Friday, equates to 37.5 hour working week)


You may live within a commutable distance from Borden, Bobbing, Newington, Kemsley, Bapchild, Lynsted, Teynham, Conyer, Ospringe, Faversham, Queenborough, Gillinghay or Canterbury

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