Medical Quality Assurance Engineer

We are looking for a QA Engineer to join our team! this is not a SW QA position

This is an ISRAELI BASED ON - SITE POSITION

Location: Netanya

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 in-house quality activities in production.

· Participate in non-conforming material processes, including investigations, MRB meetings, and implementation of corrective actions

· Support Change control process (ECO), including development and documentation of manufacturing work instructions, training, and change assessments.

· Data collection and analysis of trend (e.g., MRB, Yields).

· Review Device History Records for accuracy and completeness for product release.

· Support QC activities including in-coming, in-process and final inspection.

· Define quality requirements for production and process improvements.

A successful candidate will have the following qualifications:

· Relevant degree (e.g., biomedical, mechanical engineering or related science / technical discipline)

· 2 - 4 year of relevant experience in a similar role within a medical device company.

· CQE certification – an advantage

· Familiarity with medical device standards and regulations (MDR 2017/745, ISO 13485, FDA QSR, etc.).

· Knowledge of statistical techniques, risk analysis, root cause analysis, and process validation – an advantage.

· Ability to work under pressure to meet schedules and deadlines within quality and regulatory standards

· Strong analytical, problem-solving, and communication 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.

Requirements:

A successful candidate will have the following qualifications:

· Relevant degree (e.g., biomedical, mechanical engineering or related science / technical discipline)

· 2 - 4 year of relevant experience in a similar role within a medical device company.

· CQE certification – an advantage

· Familiarity with medical device standards and regulations (MDR 2017/745, ISO 13485, FDA QSR, etc.).

· Knowledge of statistical techniques, risk analysis, root cause analysis, and process validation – an advantage.

· Ability to work under pressure to meet schedules and deadlines within quality and regulatory standards

· Strong analytical, problem-solving, and communication 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.