Quality Engineer

About Elcam Medical

Elcam Medical is a global leader in OEM disposable medical devices and flow control solutions, partnering with leading medical device companies worldwide.

About the Role

We are looking for a Quality Engineer to serve as the Quality Assurance representative in product development, design and process validation projects. Reporting to the Quality Engineering Manager, you will work closely with R&D, Manufacturing Engineering, Sales and Marketing to make sure quality and regulatory requirements are built into our products from concept to production.

Location: On-site at our site in Bar-Am, Upper Galilee. Daily on-site presence is required.

Key Responsibilities

• Represent QA in development projects from kickoff through transfer to production; review and approve design documentation
• Lead product risk analyses (design and use) and take part in process risk reviews; update risk files after launch for technical files and customer requests
• Take part in design reviews and follow manufacturing tooling design to ensure quality requirements are implemented
• Review and approve validation documentation: VMP, IQ, OQ, PQ, PV, PFMEA and validation reports
• Define test methods in engineering specifications, including Gage R&R; define and oversee testing at external laboratories
• Review development, design and validation experiments for completeness and compliance with specifications and risk requirements
• Approve design transfer to production; define controls for, and approve release of, customer samples and at-risk production
• Support customers with engineering information, quality statements and translated validation summaries
• Prepare for and support external audits of design and validation files

Requirements

• B.Sc. in Life Sciences (engineering degree an advantage)
• At least 1 year of experience in quality assurance
• Familiarity with medical device quality assurance and regulation (e.g., ISO 13485, ISO 14971, FDA)
• Excellent English, including technical reading, writing and translation
• Knowledge of statistics
• Experience with medical devices or medical applications an advantage
• Detail-oriented, organized and assertive, able to hold your ground with professional counterparts
• Team player who takes ownership and manages time and tasks independently
• Motivated to learn and grow professionally
• Flexibility to work extended hours when needed