NEW JOB! Quality Assurance Engineer
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NEW JOB! Quality Assurance Engineer

Quality Assurance Engineer

Manufacturing Medical Devices
Full Time, Permanent
Katikati, Tauranga, Bay of Plenty

Our client is looking to add to their Quality Team and they need people with the right skills to further develop, implement and embed robust Quality Systems that are compliant with 21CFR820 and ISO 13485, participate in root cause analysis, process and design validation, test method validations, complaint investigations, new product development support, monitoring KPIs and other duties as required
Ideally we are looking for a Quality Engineer with:
·      Previous experience in developing, implementing and embedding Quality Systems in GMP regulated manufacturing environments
·      An in-depth understanding of 21CFR820 and ISO 13485
·      Previous experience in medical devices
·      Solid quality assurance knowledge and experience (5+ years) 
·      Great project management skills  
·      Training experience and the ability to assess and monitor learning outcomes
·      Bachelor’s Degree in Engineering or a related technical field, CQE and/or Six Sigma Certification
·      Validation experience (write, approve and perform test protocols, DOE, Gage R&R, ANOVA, SPC, Pareto Analysis)
·      Design control experience (review and approve DMRs, Technical Files and DHFs)
·      Proficient computer skills, MS Office and Minitab (an advantage)
·      Sound statistical knowledge
·      Internal auditing ISO13485 QMS experience (3+ years)
Based in the 'Innovation Capital' of Katikati (a short commute from Tauranga City and the beautiful beach resorts of the Coromandel and Mount Maunganui, just two hours south of Auckland) they offer the much sought after Bay of Plenty lifestyle, with the remuneration and rewards of working for an internationally acclaimed organisation.
If you are the type of person who can hit the ground running and who enjoys a fast paced, constantly changing, high growth environment we are keen to hear from you. 
Please APPLY ONLINE with your CV and Cover Letter to
Or for a confidential enquiry you can contact:
Kirsty Morrison 
One21 Recruitment
Ph: 021 355 179

One21 - For the Best in Recruiting Solutions
See further details on and
Manufacturing >  Quality Assurance & Control
Healthcare >  Pharmaceuticals and Medical Devices
Science & Technology > Quality Assurance & Control

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