QA/QC Manager - Medical Devices (EU MDR, ISO 13485)

About the role

A rapidly growing medical technology scale-up focused on customized clear aligner solutions is looking for a Quality Assurance & Quality Control (QA/QC) Manager. Reporting directly to the General Manager / CEO, the role is the sole owner of quality management, regulatory compliance and production quality control. It is a comprehensive, hands-on position establishing and maintaining the ISO 13485 QMS for Class IIa devices, leading the EU MDR CE certification end-to-end, and building quality control across manufacturing.

Key responsibilities

• Establish, implement and maintain an audit-ready ISO 13485:2016 QMS, including Quality Manuals, SOPs, work instructions and documentation
• Own the ongoing CE marking process under EU MDR (2017/745) and direct all communications and submissions with the Notified Body
• Author, update and coordinate Technical Documentation (Annex II & III), including GSPR, risk management (ISO 14971) and clinical evaluation reports
• Design and run quality control plans for raw materials, in-process thermoforming, laser marking and final packaging, and oversee batch and product release
• Plan and manage IQ/OQ/PQ, cleanroom controls and process validations
• Lead internal, supplier and Notified Body audits, and oversee post-market surveillance, vigilance reporting and EUDAMED registration
• Act as the Person Responsible for Regulatory Compliance (PRRC) under Article 15 of EU MDR

Required profile

• Bachelor's degree in engineering or life sciences; a relevant Master's is a plus
• Minimum 5 years of hands-on QA / regulatory affairs experience in medical device manufacturing
• Strong hands-on approach, comfortable working in an agile scale-up environment
• Professional English, able to draft technical dossiers and lead foreign Notified Body audits
• Nice to have: ISO 13485 Lead Auditor certification, prior PRRC experience, and background in dental devices, medical polymers, thermoforming or 3D printing

Required skills

• In-depth knowledge of ISO 13485:2016 and EU MDR (2017/745)
• Drafting technical files and managing GSPR
• Successful completion of Notified Body audits for Class IIa or higher devices