Please send us your CV by email, stating the position you are applying to: info@beyeonics.com
OPEN POSITIONS:
QA Manager
Job responsibilities:
- Managing the company’s quality system in accordance with its established procedures and in compliance with ISO13485:2016 and relevant regulations (MDR, CFR, SOR, etc.)
- Quality representative to management and leading management reviews
- Guiding and instructing company management in application and implementation of the QMS procedures
- Ownership of the documentation control process, including assignment of documents and QMS documentation maintenance
- Ownership of supplier evaluation process
- Ownership of QMS improvement processes (internal& external audits, CAPA)
- Keeping up to date with regulatory advancements including relevant standards, guidance documents, regulations, etc.
- Liasing with external parties regarding the QMS (i.e. NB, CA, EAR)
Required competencies:
- At least 4 years experience as QA manager or QA specialist in a medical device company, preferably a startup engaged in design of an active, complex medical device (i.e. containing SW, HW,FW,Mech)
- Experience in and ability to transition QMS from early design to full scale manufacturing including management of subcontractors and external production sites.
- Academic education- preferably research-based MA
- Well familiarized with core standards relevant to medical device industry (13485, 14971, 60601, 62304, 62366, 10993, etc.)
- Very high level of written and spoken English
- Ability to engage the company with quality as a core activity
- Team player with ability to coordinate different interests and provide instruction for the benefit of quality
- Organized, methodical, punctual, inquisitive, fast learner
To apply, please send your CV to: info@beyeonics.com