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QA 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.
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QA Leader
We are looking for a QA Leader to join our team! (Maternity Leave Cover with Potential for Permanent 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: This position is initially to cover maternity leave, with a very strong possibility of continuation after the original employee returns. 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: o Authors new or revised site procedures as assigned. o Assures compliance of local QMS procedure and updates as required. o 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: • 4-5 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.
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דרוש.ה טכנאי.ת ייצור - חדר נקי
אנו מחפשים טכנאי/ת ייצור לחדר נקי שיצטרפו לצוות שלנו! מיקום : צור יגאל עד הקיץ ואז נתניה ביו פרוטקט הינה חברת סטרט אפ ישראלית ותיקה בתחום הציוד הרפואי, העומדת בחזית החדשנות הרפואית בהגנה מפני קרינה. אנו מפתחים ומייצרים מוצרים המתאימים לסדרה רחבה של יישומים קליניים בתחומי האונקולוגיה והכירורגיה הכללית. המוצר הראשון של החברה - , BioProtect Balloon Implantמגן על רקמה בריאה בקרב חולים הנדרשים לקרינות במסגרת טיפולים עבור סרטן הערמונית. מה אנחנו מציעים: בתפקיד זה, תיקחו חלק בייצור מוצרים המצילים חיי אדם ומשפרים את איכות החיים של מטופלים. תנאים מעולים למתאימים – שכר, קרן השתלמות מהיום הראשון, תן ביס, כביש 6 ועוד! במסגרת התפקיד: • למידת מומחיות בתחנות העבודה השונות הכוללות הרכבה והדבקה במפעל הייצור • ביצוע תהליכי עבודה בחדר נקי תחת נהלים כתובים • מילוי טפסי ייצור בעברית ובאנגלית ועמידה בתקנים מחמירים (FDA, CE , אמ"ר) • עבודה בצוות – למידת תחנות נוספות מעבר להתמחות מרכזית • עבודה עם כלים עדינים – סקלפל, מיקרוסקופ
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