Title: Medical Device QA Lead Contract Duration: 6 months (extendable) Location: Fribourg area
Purpose of the role
This position will provide support operational Quality Assurance activities at key design, development and manufacturing vendors (in the GMP & ISO environment) for development and commercial vendors and specific internal QA support/consultancy for all Medical Devices such as drug delivery devices but more specifically medical mobile apps (Software as medical Devices), sensors and potentially IVDs. This will be achieved through close partnering with QA management at vendors sites and collaboration with Technical Operations. This position will ensure compliance to Medical Devices regulations and GMP compliance of Combination Products from a quality, safety and efficacy point of view.
Must have * Practical experience in development or QA management of Software as Medical Devices, Vital signs Sensors or IVDs * Practical experience in ISO13485, ISO14971, MDD/MDR and 21CFRpart 820 with main focus on Design Control * With either experience with 21CFR part 4 OR Medical Mobile Apps regulation
Profile * Minimum of 6 years working in the medical device industry in a quality management position. Operational GMP experience would be a distinct advantage. * Practical understanding of ISO13485:2016, MDR, ISO14971 and 21CFR820 and part 4 requirements.