Senior Quality Engineer - Switzerland

Employer
Location
Switzerland
Salary
80 - 90 CHF per hour
Posted
Jun 14, 2018
Closes
Jul 14, 2018
Ref
00041585
Contract Type
Full Time
Job Type
Technican
Jocelyn Blackham is currently recruiting for a Senior Quality Engineer to join a global healthcare organisation based in Zuchwil, Switzerland. This role is offered on a full time temporary basis for 4 - 5 months.

Your main responsibilities in this role will be to:
  • Complete development, transfer and maintenance of products/processes throughout the product lifecycle
  • Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc
  • Champion compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits
  • Approve IQ, OQ, PQ, TMV or Software Validation
  • Support new product introduction as part of design transfer
  • Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate
  • Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process
  • Support the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management

You are required to have the following qualifications, skills and experience:
  • A minimum of a Bachelor's Degree, preferably in Engineering or related technical field
  • Hands on experience in the industrial setting
  • Experience working in both an FDA and European regulatory environment is preferred
  • Relevant experience working in manufacturing/operations
  • Proven track record of implementing appropriate risk mitigation
  • Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making
  • Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred
  • A thorough understanding of GMP/ISO regulations and validation regulations is preferred

If you are employed by this client you will be joining a global healthcare company based in Zuchwil, Switzerland.

For more information or to apply for this Senior Quality Engineer position please contact Jocelyn on +44 (0)1438 842962 or email jblackham@ckagroup.co.uk. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference TC41585 in all correspondence.

Jocelyn Blackham

Head of Recruitment in Switzerland

T: 01438 842 962
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