Quality Assurance Specialist – Medical Devices (Freelance | Part-Time)

Quality Assurance Specialist – Medical Devices (Freelance | Part-Time)

Location: Northern Israel

We are a Dental Implant company operating in global markets, committed to the highest standards of quality, innovation, and regulatory compliance.

We are seeking an experienced and highly motivated Quality Assurance Specialist (Freelance | Part-Time) to support our Quality Assurance and Regulatory Affairs activities and help ensure full compliance with international standards.

Key Responsibilities

• Act as the Management Representative for the Quality Management System (QMS)
• Lead the implementation, maintenance, and continuous improvement of the QMS in accordance with ISO 13485, FDA, and MDR requirements
• Ensure full compliance with international regulatory standards, including EU MDR, FDA, and CE marking requirements
• Oversee quality processes, including internal and external audits, cleanroom monitoring in accordance with ISO 14644, and process control
• Manage customer complaints and post-market feedback (PMF), including CAPA processes
• Handle non-conformities and drive continuous improvement initiatives across the organization
• Maintain and update quality procedures and work instructions
• Lead regulatory activities, including submissions, responses, and ongoing compliance across global markets
• Manage relationships with Notified Bodies, regulatory authorities, and external consultants
• Oversee and approve subcontractors and suppliers, including quality system evaluations
• Conduct training programs to ensure company-wide QMS awareness and compliance
• Report regularly to senior management on QMS performance and regulatory status
• Work closely with cross-functional teams, including R&D, Operations, Marketing, and Sales

Requirements

• Bachelor’s degree in Science, Engineering, or a related field
• Minimum 5 years of experience managing QMS in the medical device industry
• Minimum 5 years of experience in regulatory affairs (EU MDR, FDA)
• Strong knowledge of ISO 13485 and global regulatory requirements
• Experience working with Notified Bodies and regulatory authorities
• Excellent analytical, organizational, and communication skills
• Ability to lead processes and work effectively across multiple departments
• Fluent in English (written and spoken) – mandatory

Advantages

• Experience with Class II/III medical devices
• Experience working with BSI or other Notified Bodies
• Experience with global registrations (LATAM, Asia, etc.)
• Experience in audit preparation and technical file submissions

Additional Details

·      Freelance, part-time position

·        On-site (non-hybrid)