Full Time, Permanent
Katikati, Tauranga, Bay of Plenty
DENTSPLY (N.Z) Limited is a division of Dentsply Sirona International, the worlds leading dental consumables producer who design, develop, manufacture and market a full range of professional dental products in over 120 countries. A leader in developing cutting-edge dental technology means working at DENTPSLY (N.Z.) Limited presents unlimited opportunities to grow and develop a successful career.
Right now they looking to add to their Quality Team 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, complaint management, process validation, test method validations, monitoring KPIs and other duties as required
Ideally we are looking for a Quality Systems and Assurance Specialist with:
- Previous experience in developing, implementing and enhancements to 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)
- Training experience and the ability to assess and monitor learning outcomes
- Bachelor's Degree in Engineering or a related technical field
- Internal auditing ISO13485 QMS experience (3+ years) and experience with CAPA systems
- Management of Customer Complaints
- Validation experience (write, approve and perform test protocols, DOE, Gage R&R, Pareto Analysis)
- Design control experience (review and approve DMRs, Technical Files and DHFs)
- Sound knowledge in developing and maintaining PFMEA throughout the life of device
- Proficient computer skills, MS Office and Minitab (an advantage)
- Sound statistical knowledge
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 through the Seek website with your CV and Cover Letter.
Or for a confidential enquiry you can contact:
Kirsty MorrisonOne21 – The Recruitment OutsourcerRecruiting exclusively for DENTSPLY (N.Z.) Limited
Ph: 021 355 179
ONE21 - Opening the Window of Opportunity Wider for Talent Sourcing