Senior Medical Device Quality Assurance Engineer

We are looking for a Hands on Senior Medical Device Quality Assurance Engineer (this is not software QA position) to join our team and will play significant part in the production growth!

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. Recently, BioProtect was acquired by Olympus Corporation and now operates as part of the Olympus Group.

Job Description:

The Sr. QA Engineer is responsible for leading and coordinate quality activities and ensuring compliance with applicable quality standards, and company procedures throughout production and operational activities. The role is responsible for leading quality projects and supporting ongoing manufacturing activities while enabling efficient and compliant large-scale production expansion, ensuring operational readiness, timely execution of quality activities, and maintenance of product quality. The position requires close collaboration with Production, Engineering, Supply Chain, and other cross-functional teams to ensure that project milestones, manufacturing scale-up activities, and operational timelines are achieved effectively.

In this position you will be asked to:

• Lead Change Control projects ensuring timely execution, cross-functional coordination, and implementation of manufacturing, process, equipment, material, and documentation changes.
• Provide QA oversight and review for validation activities, including:
• Equipment Qualification (IQ/OQ/PQ).
• Process validation and revalidation activities.
• Clean rooms qualification
• Validation protocols, reports, and supporting documentation.
• Verification that validation activities comply with applicable regulatory, quality, and company requirements.
• Accountable for Production risk assessments to ensure risks are identified, evaluated, mitigated, and aligned with manufacturing changes and post-production information
• Improve manufacturing work instructions to enhance clarity, compliance, efficiency, and manufacturability.
• Support manufacturing scale-up activities, including transfer to increased production volumes, implementation of new processes, and expansion of operational capabilities while ensuring compliance with quality requirements.
• Lead investigations related to production nonconformities, identify root causes, define corrective and preventive actions, and ensure timely closure and effectiveness verification.
• Monitor operational quality metrics and support initiatives to improve product quality, production yield, and process performance.
• Collaborate with cross-functional teams to support continuous improvement initiatives.
• Support internal and external audits, inspections, and regulatory activities related to manufacturing and QA Operations.

A successful candidate will have the following qualifications:

• Relevant degree (e.g., biomedical, mechanical engineering or related science / technical discipline)
• At least 4-5 years’ related experience as a quality engineer, 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 QMSR, etc.)
• Experience with:
• statistical techniques
• risk analysis (PFMEA)
• root cause analysis techniques
• Process validation
• 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)
• Experience with Class III implantable medical devices – an advantage
• Experience with working in controlled environment (clean room) – an advantage

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.