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Medical Product Quality Engineer - Oberdorf

Switzerland   •  Contract/Temporary, Full time

Alex Tosney is recruiting for a Medical Product Quality Engineer to join a leading medical device manufacturer on their site based in Oberdorf, Switzerland. This is a fantastic opportunity to join a company making a real difference to patients lives for an initial 5 month contract. This role is offering an attractive rate of up to 110 CHF per hour for a 40 hour week.

The main purpose of the Product Quality Engineer role will be to lead and implement complex projects including quality improvement initiatives.

Further responsibilities of this Product Quality Engineer position will include:
• Working knowledge of basic and advanced statistical methods (e.g., hypothesis testing, DOE, ANOVA, R&R studies, capability, tolerance interval analysis, power and sample size determinations, etc.).
• Demonstrating strong project management skills and lead cross-functional teams.
• Working knowledge of risk assessment tools (e.g., ISO 14971, FMEA's, FTA).
• Demonstrating working knowledge of Post Market Surveillance.
• In-depth knowledge of quality engineering principles and methodologies.
• Working knowledge of process validation strategies (inclusive of I/O/P).
• In-depth knowledge of Design Controls, CAPA, NC, etc.
• Providing leadership in understanding of the regulations to other disciplines.
• Supporting and leading product Design Control activities for new product development efforts.
• Conducting and leading Process/Design Validation/Verification activities and approach including software validation.
• Conducting Process/Design Risk Analysis.
• Supporting Manufacturing Engineering in the creation of travelers, routes, bills of material, print changes, and specifications for in-house manufacturing.
• Conducting Internal Audits of the Quality System.
• Conducting audits of new suppliers as part of the project teams.

As a Product Quality Engineer, you will have the following qualifications, skills and experience:
• Degree qualified or equivalent in a technical discipline with related experience in a quality engineering function
• Experience of direct and/or related quality work experience in a regulated environment.
• Knowledge of the CFR820 and ISO 134585 quality requirements. 

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 and 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 ENG40366 in all correspondence.


You MUST be eligible to work in Switzerland. Learn more

  • Agency: CK Group (Science, Clinical, Engineers and IT Recruitment)
  • Posted: 13th October 2017
  • Expires: 10th November 2017
  • Reference: ENG40366
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Contact

  • Recruiter: Alex Tosney
  • Phone: 01246 457730