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QA Validation & Product Lead
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 manage and oversee overall validation activities and ensure compliance with quality and regulatory requirements while supporting the organization’s goals.
This position reports directly to the QA/RA Director, reflecting its critical role in maintaining and enhancing quality standards.
In this position you will be asked to:
• Establish and review design V&V, excel files validation, and process validation protocols in accordance with standards and regulation requirements
• Evaluate processes and equipment to ensure regulatory and quality compliance.
• Review validation plans, test results, and summary reports for regulatory compliance
• Provide guidance on quality/regulatory requirements for validation activities, including production, manufacturing, user requirements specifications, and testing strategies.
• Offer cross-departmental support to ensure adherence to ISO13485, FDA requirements, and other applicable quality, validation guidance and regulations, including performing standards gap assessments.
• Understands validation/technical problems and evaluates their potential impact on product quality
• Evaluate potential impact of validations as part of change control process
• Provide quality assurance monitoring of projects to assure regulatory compliance of validation and design processes,
• Maintain the device risk management file
• Maintain Traceability matrices
• Participate in cross-functional teams to define validation strategies and objectives that support organizational needs.
• Participate in projects as a design team member to ensure proper selection of new equipment in support of validation.
A successful candidate will have the following qualifications:
• 4-7 years of experience within a medical device company
• Strong knowledge of medical device standards and background in qualification documentation review
• B.Sc. Engineer in Biomedical/Biotechnology – an advantage
• Experience in data analysis – an advantage
• Strong technical and engineering knowledge - – an advantage
• Excellent written and verbal communication skills in both Hebrew and English
• A team player with strong communication and collaboration skills
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.
Engineering Project Manager
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 lead the engineering activities in the production line.
In this position you will be asked to:
• Lead engineering projects to support the production line.
• Manage the life cycle of production machines and jigs, including writing specifications, designing, testing, validating and line engineering.
• Manage and perform equipment and processes validation (IQ, OQ and PQ).
• Support the design and development of a scale up facility.
• Lead the installation and process definitions of tools
• Write documents for the production line, such as work instructions and production forms.
• Be hands-on in solving problems in production
• Troubleshoot issues related to the manufacturing equipment and the cleanroom environment.
• Work closely with Operation and Quality teams.
A successful candidate will have the following qualifications:
• B.Sc in Mechanical Engineering – must.
• Engineering background in multidisciplinary machine design and manufacturing.
• 5+ years of experience in medical device companies.
• Experience in production line technical support, proven experience in cleanrooms.
• Proven experience in process validations and qualification IQ/OQ/PQ.
• High technical writing abilities and experience in documentation.
• Proficiency in Solid works (and PDM)
• Excellent communication and interpersonal skills, include the ability to work independently as well as within a team.
• Fluent English and Hebrew (written and verbal).
Operations Coordinator
We are looking for an Operations Coordinator to join our team!
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 be part of the supply chain team and will collaborate with various departments, including Engineering, Quality, Finance, Production.
In this position you will be asked to:
• Taking a significant part in all the company’s procurement activities including engineering, R&D, manufacturing and office supply.
• Sourcing of new vendors and performing purchasing cost reductions
• Coordination of routine and ad-hoc calibrations
• Responsible for part specifications writing and approval with QA
• Equipment management in the ERP (part numbers, serials, BOM, spare parts)
• Warehouse support as needed - receiving inventory, logistic incoming inspection, supplying materials to production, inc. consumables etc.
A successful candidate will have the following qualifications:
• 1-2 years of experience in an operational position, preferably from a highly regulated industry
• Experience in Procurement and other supply chain day-to-day activities
• Bachelor’s degree in industrial engineering or in similar fields
• Experience with Priority – major advantage
• High level of English
• Excellent communication skills
• High attention to details
• High level of service
• Desire to learn and evolve with the company
This position might be require occasionally work in Tzur Yigal site
BioProtect is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, 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.
QA Leader
We are looking for a QA Leader to join our team!
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 support manufacturing and operation with establishment and overall responsibility of Change Control processes.
In this position you will be asked to:
• Review and approve qualification and validation plans, protocols, and reports for compliance with the requirements, and the applicable regulations.
• 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, and other documentation.
Cleanroom Production Technician
We are looking for a Cleanroom Production Technician to join our team!
Location: Netanya
BioProtect is an established Israeli startup in the medical device field, leading innovation in radiation protection. We develop and manufacture products suitable for a wide range of clinical applications in oncology and general surgery. The company’s flagship product, the BioProtect Balloon Implant, protects healthy tissue in patients undergoing radiation therapy for prostate cancer.
What We Offer:
In this role, you will participate in manufacturing products that improve patients' quality of life. Excellent conditions for suitable candidates include competitive salary, advanced training fund from day one, meal card, Highway 6 access, and more!
Responsibilities:
• Learning the expertise of various workstations, including assembly
• Performing work processes in a cleanroom under written procedures.
• Filling out production forms in Hebrew and English and adhering to strict standards
• Teamwork—learning additional workstations beyond your primary specialization
• Working with delicate tools—scalpel, microscope.
BioProtect is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, 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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