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About The Position
- Implement, monitor, maintain and support quality assurance activities, throughout life cycle of Alma Lasers company, subsidiaries and products
- Review, edit and maintain all pre-established QMS policies including training, CAPAs, ECOs and MRBs.
- Participate and support in training procedures and processes
- Participate and support Alma daily QA activities
- Prepare and participate in internal and external audits and certification tasks for CE, ISO 13485, MDSAP, FDA etc..
- Work with international bodies such as Notified Bodies and regulatory consultants.
- Prepare management reviews.
- Support QA goals to align with company’s long-term strategy and regulatory requirements
- Review quality agreements.
- Support validation activities related to product release procedures (e.g. sterilization, packaging, transportation)
- Proactively involve with Eng/RD with the ability to support to D&D activities
- Support process & production risk management file and cross functional related activities
- Supporting product risk management file and cross functional related activities
Requirements
- Bachelor’s degree in Life Sciences, Engineering, or a related field. Advanced degree preferred.
- Minimum of 4 years of experience in QA of medical device (ISO 13485).
- Experience with class IIb HW&SW product strong advantage
- Experience with global QMS advantage
- Strong knowledge of Quality is other industries (cosmetics, SW etc..) is an advantage
- Strong attention to detail and ability to work independently.
- Excellent written and verbal communication skills.
- English full proficiency
Let’s talk about your future
