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QA Vendor Lead

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QA Vendor Lead
Main Requirements:

Must Have: 
  • Min 2-3 years of experience in combination products 
  • Min 5 years of experience in vendor management and a strong experience in quality 
  • Practical experience in ISO13485, ISO14971, MDD/MDR and 21CFRpart 820 with main focus on product life cycle management and supplier management
  • Experience with 21CFR part 4 OR Medical Mobile Apps regulation
Main responsibility:
  • Provide expert advice, support and management for technical operational QA and general QA matters for specific vendors, in manufacturing and life-cycle management of medical devices and combination products ensuring application of ISO and GMP requirements.
  • Review and approve protocols and reports for Verification and Validation studies, technology transfers, stability studies, etc...
  • Ensure risk assessments are performed and kept up to date
  • Oversee inspection plans at CMO including qualification, monitoring and routine auditing
  • Provide expert support to internal partners to assure systems are in place
  • Facilitate investigations and resolution of issues relating to deviation and change management
  • Review and approve deviations during commercial activities
  • Lead/review critical investigations
  • Track CAPA events and closure
  • Oversee/track Design change controls
  • Ensure application of ISO, MDR and GMP requirements where applicable
  • Review and approve documentation
  • Review and approve vendors documentations
  • Perform gap analysis, support remediation and insure compliance of the device Technical Documentation File as required
  • Ensure Design History File (DHF) is in place and up to date
  • Accommodate design & technology transfer and ensure systems alignment with vendors 
Profile:
  • Minimum of 5 years working in the pharmaceutical/biologics/medical device industry in quality management position. Operational GMP experience or clinical activities experience would be a distinct advantage.
  • Practical understanding of ISO13485:2016, MDR, ISO14971 and 21CFR820 and part 4 requirements.
  • Very good level in English, French is a plus 
Text

Overall rating

3,8

Based on 57 reviews

2,3 Career / Further education
3,2 Salary / Social benefits
3,8 Work-life balance
2,3 Management

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