QMS Harmonization Specialist (Medical Devices) vacancy for a globally operating Basel based company in the pharmaceutical sector.
MUST HAVE: Experience in Quality Management Systems (QMS) in Medical Devices
1. Minimum Bachelor’s degree in Engineering, Life Sciences, or Physical Sciences
2. Ability to meet deadlines efficiently
3. 3+ years’ experience in medical device, pharmaceutical or other highly regulated industries
4. Excellent knowledge of European and US regulations and standards such as MDR, ISO 13485 and FDA QSR (21 CFR 820)
1. Write new SOPs or update existing ones about processes and interactions with other departments
2. Write and explain processes in a clear, concise and efficient manner
3. Create complex process graphs, using visuals and workflow
4. Support project team members, in deployment, harmonization and continual improvement of QMS
5. Interact with process Subject Matter Expert (SMEs) in the frame of Quality systems improvement initiatives, follow-up activities, meeting preparation (data collection/ metrics) and completion of assigned actions
Location: Basel, Switzerland
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