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Location Lausanne, Switzerland
Date Posted 01/12/2019
Category Medical Device
Job Type CDI
Disponiblité A discuter
Education Level Master
Experience > 5 years

Description

Mission:

Act as Deputy of the Quality Assurance Manager.

In charge of the customer complaints handling system.

Responsible for software validations.

Lead the Quality training program.

Monitor compliance to procedures, perform internal audits and update the QMS documentation accordingly.

Develop product expertise within the QA department to support V&V activities

Profil

Obligatoire:

+5 years of relevant Quality Assurance experience in a medical device company developing, manufacturing and marketing technically complex equipment that includes software, hardware and mechanics.

Expertise in medical device Quality Management systems (ISO13485, 21CFR part 820) and in the regulatory landscape (MDD and MDR), preferably with a focus on compliance to software development (ISO62304) and on root cause analysis.

Certified internal auditor.

Degree in Engineering, preferably with an additional education in Quality Assurance.

Excellent documentation and communication skills.

Fluent in English and French.

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