A leading medical device company in Yokneam is looking for an NPD Quality & Compliance Engineer for a temporary maternity cover.
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.
