Quality Assurance Lead

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

Location: Tzur Yigal/ Netany

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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 cance

r.

The opportuni

ty: In this role, you will support manufacturing and operation with establishment and overall responsibility of Change Control proces

ses.
In this position you will be aske

d to:• Review and approve qualification and validation plans, protocols, and reports for compliance with the requirements, and the applicable regulat

ions.• Maintain the QMS to fulfill quality and regulatory requirem

ents:o Authors new or revised site procedures as assi

gned.o Assures compliance of local QMS procedure and updates as requ

ired.o Maintains the effectiveness of the QMS in accordance with the company objectives and applicable require

ments• Executes QA activities in line with defined procedures and processes: CAPA non-conformities, training, document co

ntrol• Ensures that all suppliers used by the company are selected, evaluated and re-evaluated and that records of this assessment are mainta

ined.• Ensures quality records are established and maintained to provide evidence of the QMS effective

ness.• Review, edit and approve change controls, work-instructions, and other documenta

tion.
A successful candidate will have the following qualificat

ions: • 4-5 years’ related experience in a medical device c

ompany• Experience and knowledge with standards and regulations (MDR 2017/745, ISO 13485, FD

A QSR)• Experience with validation documentation

review• Experience with statistical techniques, risk an

alysis• Excellent English language skills (verbal and wr

iting)• Relevant degree (e.g., biomedical engineering or related science / technical disci

pline)
Bonus

Points:• Experience with Class III implantable medical

devices• Experience with working in controlled environment (clea

n 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 lo