Quality Engineer

We are looking for a QA Engineer to join our team!

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 Oversee and assess the quality of manufacturing process

In this position you will be asked to:

• Support quality activities in production (in-house and outsourced)
• Data collection and analysis of trend (e.g., MRB, Yields) in the manufacturing site.
• Review manufacturing-related paperwork in the Device History Record for accuracy and completeness
• Support QC activities including in-coming, in-process and final inspection (product release), label inspections
• Participate in the resolution of all product rejections and returns, internal and external, call and follow-up on Material Review Board Meetings
• Participating in investigations in the production related to nonconforming products
• Developing and documenting manufacturing work instructions together with Engineering
• Determination of quality requirements for production and processes improvements

A successful candidate will have the following qualifications:

• Relevant degree (e.g., biomedical, mechanical engineering or related science / technical discipline)
• At least 2 years’ related experience, in a similar role, in a medical device company
• CQE – an advantage
• Experience and knowledge with standards and regulations (MDR 2017/745, ISO 13485, FDA QSR, etc.)
• Experience with statistical techniques, risk analysis, root cause analysis, Process validation etc. an advantage
• Ability to work under pressure to meet schedules and deadlines within quality and regulatory standards
• Strong verbal and written communication skills
• Strong analytical skills
• Strong problem-solving skills
• Excellent English language skills (verbal and writing)

Bonus Points:

• 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.