Quality Management Representative (QMR)

Acrostak is a global leader in health technology, committed to improving hundreds of thousands of lives worldwide through optimized manufacturing and innovation. We are looking for a Quality Management Representative (QMR) who brings both regulatory rigor and business sense to the table — someone who understands that quality and speed are not opposites, but partners.

In this role, you will serve as the primary interface between our quality management system and all internal departments, ensuring that processes, documentation, and continuous improvement activities meet the highest standards — while keeping in touch with operational and commercial realities.

• Maintain, develop, and continuously improve the Quality Management System (QMS) in line with ISO 13485 and applicable regulatory requirements
• Act as the primary point of contact for regulatory authorities, notified bodies, and internal stakeholders on all QMS-related matters
• Plan, coordinate, and lead internal and external audits; track and close CAPAs effectively and on time
• Prepare and present quality metrics, KPIs, and management review reports to senior leadership with clarity and confidence
• Collaborate cross-functionally with R&D, Operations, Regulatory Affairs, and Commercial teams to embed quality throughout all business processes
• Drive a culture of quality awareness across the organization through training, coaching, and clear communication

• Bachelor’s degree in engineering, Life Sciences, or a related technical discipline
• 5+ years of quality management experience in the medical device or regulated healthcare industry
• Proven experience managing a Quality Management System (QMS) in compliance with ISO 13485
• Familiarity with FDA QSR (21 CFR Part 820) and EU Medical Device Regulation (MDR 2017/745) is a strong advantage
• Demonstrated experience in audit management, CAPA processes, and regulatory submissions
• Fluent in English, both written and spoken
• Knowledge of German and/or French is advantageous
• Experience with Greenlight Guru eQMS is a plus
• Swiss work permit or European citizenship required — the company will not consider candidates requiring visa sponsorship

• A self-starter who takes ownership, follows through, and thrives in a fast-paced, international environment — with a hands-on solution-oriented approach.
• A confident professional who builds trust and communicates effectively across regulatory authorities, executive leadership, and operational teams.
• Someone who can translate quality and regulatory requirements into pragmatic, business-sensible solutions.
• A strategic thinker who knows how to balance the company’s priorities and put the effort where it counts the most.
• Strong people skills and the ability to understand when to push and when to show flexibility.

Join a dynamic team in rapid expansion, where your contributions are visible and valued from day one. You will have real ownership and the opportunity to grow alongside the company, working on technologies aimed at treating vascular diseases and making a tangible difference in patients’ lives.