Description
- 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
What We Do
You already know we create amazing technology that helps millions around the world to live better, more confident lives. You also know that we are at the top of the medical aesthetic market.
But we’re here to tell you we are way more than that.
We realized that in the modern life, a better way to make innovative technology, is understanding what our partners and their patients really want. To put people and their needs first. So we became better at listening and translating the true needs of your patients into outstanding and cutting-edge technology.
We are transforming together. With you. This is what we been doing for the last 20 years. This is what got us to be a leading player in the medical aesthetics field. We take pride being number 1 in China and number 3 globally, and we owe this accomplishment to our people, our partners and our daring spirit. We infuse this spirit in everything we do and we invite you to join us.
Whatever comes next we are there.
Alma Lasers is a global innovator of laser, light-based, radiofrequency and ultrasound solutions for the aesthetic and surgical markets.
Alma Lasers has been at the forefront of multi-technology systems, revolutionizing existing treatment methods and working to serve the varied and growing needs of both patients and practitioners around the world.
With offices, R&D and manufacturing facilities on three continents and distributors around the world, Alma's mission is to provide modular, cost-effective and high-performance systems based on the very latest clinical research and cutting-edge technology. We enable practitioners to offer safe, effective and profitable aesthetic and surgical treatments to their patients, while allowing patients to benefit from the capabilities of state-of-the-art, clinically proven technologies and methods.
