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Quality Assurance Specialist

Radix Engineering

יקנעם עילית

Quality Assurance Specialist

Radix Engineering

יקנעם עילית
היברידית
20,000-30,000 ₪ (הערכה מבוססת AI)
זוהי הערכת טווח שכר מבוססת AI ולא פרסום של המעסיק

We're Hiring | Quality & Compliance Engineer

📍 Location: Yokneam | Hybrid

We're looking for a Quality & Compliance Engineer to join our growing R&D team and lead quality and regulatory processes across the product development lifecycle.

If you’re passionate about quality, have a strong background in medical device regulations, and enjoy working in a collaborative environment – we’d love to meet you.

What you’ll do:

Lead quality and compliance activities throughout product development
Implement quality processes and standards for new product introduction (internal & external regulations)
Provide quality input to project teams, participate in design reviews and design changes
Review and approve project deliverables, including credibility checks
Define and maintain quality plans and metrics for R&D projects
Manage the Design History File (DHF) and perform audits as part of design control
Lead risk management processes (FMEAs, risk plans, reports)
Ensure proper documentation of compliance and compatibility declarations
Participate in release readiness reviews and approve documentation in Agile PLM
Manage documentation lifecycle including version control and approvals in Agile

Requirements:

Bachelor’s degree – required
Preferred: BSc in Engineering, Mechanical Engineering, Quality, Statistics, or similar
Proven experience as a Quality Engineer – preferably in a medical device company
Familiarity with key standards and regulations:
ISO 13485, ISO 14971, IEC 82304, ISO 27001, QSR 21 CFR 820
EU MDR 2017/745 & Directive 93/42/EEC
Advantage: experience with HIPAA, GDPR, 21 CFR Part 11, GAMP 5, Annex 11

Skills: