Quality Assurance & Quality Control (QA/QC) Manager

About Our Partner

Our partner is a rapidly growing, innovative medical technology scale-up operating at the intersection of dental biotechnology, digital dentistry, and advanced manufacturing. Focused on customized clear aligner solutions, the company integrates state-of-the-art 3D digital planning, additive manufacturing, and automated thermoforming technologies to deliver high-precision medical devices.

Operating with an agile, high-ownership, and entrepreneurial mindset, our partner fosters an environment where team members take full responsibility for their domain, make fast decisions, and build scalable systems from the ground up.

Position Overview

Reporting directly to the General Manager / CEO, the Quality Assurance & Quality Control (QA/QC) Manager will be the sole owner and strategic driver of the company’s quality management, regulatory compliance, and production quality control operations.

This is a comprehensive, hands-on role where you will establish, maintain, and continuously improve the ISO 13485 Quality Management System for Class IIa medical devices, lead the ongoing EU MDR CE certification process end-to-end, and build robust quality control mechanisms across all manufacturing processes.

Key Responsibilities

• Quality Management System (QMS): Establish, implement, and maintain an audit-ready ISO 13485:2016 compliant QMS tailored to the company’s Class IIa medical device operations. Author and manage all Quality Manuals, SOPs, work instructions, and documentation.
• EU MDR & CE Certification: Take full ownership of the ongoing CE marking process under EU MDR (2017/745). Direct all communications and submissions with the Notified Body.
• Technical Documentation: Author, update, and coordinate the complete Technical Documentation (Annex II & III), including General Safety and Performance Requirements (GSPR), Risk Management (ISO 14971), and Clinical Evaluation Reports (CER).
• Production Quality Control (QC): Design and execute quality control plans across incoming raw materials, in-process thermoforming, laser marking, and final packaging. Oversee batch release and product release processes.
• Process & Equipment Validation: Plan and manage equipment qualifications (IQ/OQ/PQ), cleanroom/environmental controls, and process validations to ensure consistent manufacturing performance.
• Audits & Post-Market Activities: Plan and lead internal audits, supplier audits, and external Notified Body audits. Oversee Post-Market Surveillance (PMS), vigilance reporting, and Product Tracking System (ÜTS/EUDAMED) registrations.
• Regulatory Responsibility: Fulfill the role of Person Responsible for Regulatory Compliance (PRRC) under Article 15 of EU MDR.

Qualifications & Requirements

• Education: Bachelor’s degree in Engineering (Biomedical, Chemical, Materials, Mechanical, Industrial) or Life Sciences (Chemistry, Biochemistry, Biology, Pharmacy). A relevant Master’s degree is a plus.
• Experience: Minimum 5+ years of hands-on Quality Assurance / Regulatory Affairs experience within the medical device manufacturing industry.
• Regulatory Expertise: In-depth, practical knowledge of ISO 13485:2016 and EU MDR (2017/745). Proven track record of drafting technical files, managing GSPR, and successfully completing Notified Body audits for Class IIa or higher devices.
• Mindset & Working Style: Strong "hands-on" orientation—willingness to directly author procedures, execute validation protocols, and manage floor-level QC rather than delegating solely to consultants. Comfortable working in an agile, scale-up environment.
• Language Skills: Professional working proficiency in English (written and verbal), capable of independently drafting technical dossiers and leading foreign Notified Body audits.
• Nice to Have: ISO 13485 Lead Auditor certification; prior experience as an official PRRC; background in dental devices, medical polymers, thermoforming, or 3D printing technologies.