Senior Quality System Engineer (Medical Device)
Medical Device Manufacturer With Cutting Edge Technologies
Exciting Opportunity In A New Start-Up
About Our Client
New start-up in the medical device industry with cutting edge technologies is recruiting for an experienced Quality System Engineer / Senior Engineer to join their growing team and collaborate closely with other functions.
The Quality System Engineer / Senior Engineer will be responsible to develop and maintain the QMS, SOPs and manuals and ensure compliance to QSR Part 820 and ISO 13485. This role will be conducting internal audits, prepare all necessary documentation for external audits and collecting & collating the data required. Part of the role also includes developing QMS training materials for the organization, conducting gap analysis of revised regulations & standards and also assisting in the preparation of regulatory product submission and assessing the impact of product & process change.
The Successful Applicant
- Bachelor / Diploma in Engineering or related discipline
3-5 years in a quality assurance / quality systems role in the medical device industry. Familiar with ISO 3485 and knowledge of CMDCAS and QSR Part 820 is desired.
What's on Offer
Retaining the intimacy of a small company, the firm offers the breadth of resources and opportunities of a global organization to their fellow staff.