Role DescriptionThe Quality Assurance Manager will play a key role with our new product introduction team that are taken from concept, design, development to commercialisation. The products from the local site consists is focused on software. The QA Manager in Belgium will ensure compliance with industry guidelines, regulatory standards and company requirements. Responsibilities will also include interfacing with team members from teams such as Marketing, R&D, Manufacturing, Support and Clinical as well as outside organisations such as suppliers, test facilities and regulatory bodies.
Responsibilities1. Develops, implements and maintains Quality Management system and activities within FDA QSR 820, ISO 13485, ISO 27001 and international regulatory guidelines. 2. Serves as site management representative with responsibility for reporting on the performance of the quality system and any need for improvement to top management. 3. Serve as the quality representative for new product introduction and new product improvement projects for all product types; participate in team meetings and coordinate quality activities as required. Focus will be on the clinical bioinformatics software products like Alissa Interpret and Align and Call. 4. Assist in development and execution of regulatory plans for complex projects. Assist in documentation for regulatory meetings with FDA. 5. Monitor applicable regulatory requirements; assure compliance with internal procedures and external standards. 6. Assist with the verification and validation experimental design; coordinate with regulatory affairs and R&D to confirm experimental design conforms to appropriate regulatory requirements.
Requirements1. Bachelors or Master's Degree 2. Solid understanding of medical device design control and regulations as well as Medical Device quality management standards ISO 13485, FDA 21 CFR part 820, EU Medical regulations, ISO 14971, IEC 60601, 62304, 62366. 3. Experience with Medical Software and Electro Mechenical standards is a big pre (IEC 60601 & IEC 62304)
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Jeroen Evertsen.