Medical device Quality Assurance Lead

***NOT A SOFTWARE QA POSITION, thank you***

Location: Tzur Yigal

BioProtect Ltd is a leading medical start up in radiation protection technology. We offer spacers protecting healthy tissue during radiation oncology treatments, based on proprietary biodegradable balloon technology. The balloons suit a wide range of clinical applications in the fields of oncology and general surgery. The company’s first product, the BioProtect Balloon Implant, protects healthy tissue in patients undergoing radiation therapy for prostate cancer.

The opportunity:

In this role, you will support manufacturing and operation with establishment and overall responsibility of Change Control processes.

In this position you will be asked to:

• Maintain the QMS to fulfill quality and regulatory requirements:
• Authors new or revised site procedures as assigned.
• Assures compliance of local QMS procedure and updates as required.
• Maintains the effectiveness of the QMS in accordance with the company objectives and applicable requirements
• Executes QA activities in line with defined procedures and processes: CAPA non-conformities, training, document control
• Ensures that all suppliers used by the company are selected, evaluated and re-evaluated and that records of this assessment are maintained.
• Ensures quality records are established and maintained to provide evidence of the QMS effectiveness.
• Review, edit and approve change controls, work-instructions, reports and other documentation.

A successful candidate will have the following qualifications:

3 - 6 years’ related experience in a medical device company

• Experience and knowledge with standards and regulations (MDR 2017/745, ISO 13485, FDA QSR)
• Experience with statistical techniques, risk analysis
• Excellent English language skills (verbal and writing)
• Relevant degree (e.g., biomedical engineering or related science / technical discipline)

Bonus Points:

• CQE and process validation knowledge
• Experience with Class III implantable medical devices
• Experience with working in controlled environment (clean room)

BioProtect is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.