Quality Manager (f/m/nb)

Location: Amsterdam, The Netherlands
32–40 hours per week on-site

About Flash Pathology

Flash Pathology is an Amsterdam-based MedTech startup developing innovative histology solutions that redefine tissue imaging and cancer diagnostics. With our rapid on-site microscopes, we empower clinicians, pathologists and researchers with real-time high-quality tissue insights, enabling faster decisions, improved outcomes, and more efficient workflows in surgical and biopsy settings. As we continue to grow, we are expanding our team and operations to bring next‑generation tissue imaging capabilities to laboratories and hospitals worldwide.

Your Role

As Quality Manager you are responsible for owning and executing key processes within the Quality Management System (QMS), ensuring product quality, patient safety, and compliance with ISO 13485 and other applicable regulatory requirements. This hands-on role collaborates closely with cross-functional teams to maintain and reinforce quality standards throughout the entire product lifecycle. It also involves the creation, maintenance, and control of technical documentation and quality records, ensuring traceability, accuracy, and compliance with internal procedures and external audit expectations.

Key Responsibilities

Own and maintain assigned Quality Management System (QMS) processes, ensuring accurate and compliant technical documentation and quality records
Manage complaints, non-conformances, and CAPA activities, ensuring effective root cause analysis and corrective actions
Conduct internal audits and support audit readiness for regulatory and notified body inspections
Oversee supplier quality documentation, performance monitoring, and continuous improvement initiatives
Execute product release activities with full compliance, traceability, and adherence to regulatory requirements
Support and contribute to regulatory documentation, including alignment with ISO 13485 and applicable global regulations
Provide cross-functional quality guidance, training support, and ensure alignment with quality standards across teams
Contribute to the definition and implementation of regulatory strategy, ensuring alignment with product and business objectives
Ensure projects are developed in compliance with applicable quality and regulatory requirements, supporting design and development controls
Lead and support risk management activities throughout the product lifecycle, including risk assessments and mitigation tracking
Support post-market surveillance activities, including complaint trending, vigilance reporting, and feedback analysis
Monitor and analyze trends from manufacturing processes and quality data to drive continuous improvement and prevent recurrence of issues

What You Bring

Bachelor’s degree in Science, Engineering, or Quality-related field
2–5 years QA experience in medical device or pharmaceutical industry
Strong working knowledge of ISO 13485 and regulated QMS environments
Experience with complaint handling, CAPA, audits, and supplier quality
Detail-oriented with disciplined documentation and compliance focus
Flexibility, initiative, and a hands-on mindset suited to a fast-paced scale-up
Strong organizational, collaboration, and communication skills (English required; Dutch is a plus)

What We Offer

A pivotal role in bringing breakthrough histology solutions to market
A dynamic, purpose-driven culture within an innovative and fast-growing start-up
A small international team, where you’ll make significant contributions
Competitive salary dependent on experience

As a start-up, we know that learning on the job is part of the journey so if you don’t meet every requirement, but are enthusiastic about the role and our mission, we still encourage you to apply.

Candidates must have a valid work permit as Flash Pathology is not recognized as a sponsor with the Immigration and Naturalization Service (IND).

Please send your CV and a brief cover letter to:
jobs@flashpathology.com

Deadline for applying is 19 May 2026.