Quality Assurance Specialist

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

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.