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
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.