Quality Assurance Engineer

A leading medical device company in Yokneam is looking for an NPD Quality & Compliance Engineer ****for a temporary position*****

The purpose of this position is to ensure that products are developed in compliance with the quality assurance system throughout the product lifecycle. The role includes leading NPD Quality & Compliance activities, ensuring adherence to quality standards and processes, managing product and tools/jigs Design History Files (DHF), performing risk and defect management, supporting operations projects, and participating in audits and product release activities.

Key Responsibilities

• Lead Quality & Compliance activities during product development (NPD and engineering versions).
• Implement Quality & Compliance processes and standards for new product introduction.
• Provide quality input to project teams, participate in design reviews and design changes, and review/approve project deliverables.
• Perform credibility checks for project deliverables.
• Define Quality Plans and metrics for R&D projects, and provide regular updates.
• Manage DHFs for products, tools, and jigs, including audits as part of design controls.
• Accountable for Risk Management process throughout the PDP and PMS, including FMEAs.
• Responsible for product Declarations of Compatibility (DOC) and Declarations of Compliance.
• Support global quality activities, including CER, PMS, and CRRs.
• Participate in product release, review and approve ECOs.
• Investigate incidents, participate in Defect Classification Board, rank defects, review clinical readiness results, and escalate potential quality and safety issues.
• Prepare for and support internal and external audits.
• Lead or participate in quality improvement initiatives for products and processes.

Qualifications & Skills

• Bachelor’s degree required; preferably BSc in Engineering, Mechanical Engineering, Quality, Statistics, or equivalent.
• Experience as a Quality Engineer, preferably in medical devices, with direct involvement in product development (NPD).
• Knowledge of ISO 13485, EN ISO 14971, QSR 21 CFR 820, EU MDR 2017/745, and related standards.
• Advantage: Six Sigma methodology experience, application of statistical methods in product design, CQE/CSQE/CRE certifications.
• Strong interpersonal, communication, and strategic thinking skills; self-motivated, results-oriented, and detail-focused.