Senior Quality Design Assurance Engineer

Olympus is recruiting on behalf of BioProtect, its fully owned entity dedicated to advancing prostate cancer care through innovative spacing solutions.

We are recruiting for a Senior Quality Design Assurance Engineer who will be responsible for the design, development and management of new products under development.

Working with internal/external manufacturers providing finished products, services, components, and sub-assemblies to ensure compliance with company policies and procedures and medical device regulations. This role will partner with Operations, R&D, Supply Chain and other departments to continuously improve products and processes that meet all internal and external requirements and regulations.

What you will be doing

• Drive the design & execution of Production Release Process project for components & finished devices

• Lead and implement complex projects including quality improvement initiatives

• Set direction for cross-functional teams and drives towards compliant and efficient solutions to complex problems

• Lead Process/Design risk analysis

• Lead product design control activities for new product development efforts

• Provide leadership in understanding of the quality regulations to other disciplines

• Support Process/Design Validation/Verification activities and approach including software validation

• Lead implementing limited cost of quality concepts, including cost of quality, data collection, & reporting

• Support Manufacturing Engineering in the creation of DMR, DHR, routes, and bills of material, print changes, and specifications for in-house / external manufacturing

Who we are looking for

We're looking for a collaborative Quality Engineer who is passionate about improving products, solving complex challenges, and making a real difference to patient outcomes. You'll enjoy working in a fast-paced, regulated environment where quality, innovation, and continuous improvement go hand in hand. To succeed in this role, you'll bring:

• A Bachelor's degree in Engineering or a related discipline

• At least 5 years' experience in Quality Engineering within an FDA-regulated medical device or similarly regulated environment

• Experience supporting sustaining engineering activities and post-market surveillance

• A strong understanding of quality and regulatory standards, including FDA QSR, ISO 13485, ISO 14971, ISO 11135, and EU MDR

• Practical experience using Six Sigma tools and structured problem-solving techniques to drive continuous improvement

• Excellent communication and stakeholder management skills, with the ability to collaborate across cross-functional teams

• A proactive, analytical mindset and the ability to thrive in a dynamic, fast-moving environment where priorities can evolve

What we offer you

We offer a competitive salary and a locally competitive benefits package designed for employees based in Israel. In addition to statutory employment benefits, you'll have access to company benefits that support your wellbeing, development, and work-life balance. We'll be happy to share the full details during the interview process.

If this role sounds like your next career move, we look forward to receiving your application. Please note, that all application documents should be submitted in English.