549 jobs in Bulle found

Subscribe to this job search
Please fill in
By submitting the form, you agree to our Terms and Conditions and the Privacy Policy.
Please check your email account to complete the subscription.
Job notification
Job notification

QA Vendor Lead

add review
Rating submitted
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 
  • 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 

Overall rating


Based on 57 reviews

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

Add review

Enter your rating for the company Randstad (Schweiz) AG here!

Rating submitted