Quality Technician (Medical Devices)

Location: Waalwijk, Netherlands

Company

hirify.global is a medical device company developing the Omnipod platform for wearable insulin delivery and other subcutaneous drug-delivery applications.

What you will do

• Perform post-market investigations, material assessments, initial inspections, and data extraction from returned medical devices.
• Implement and maintain effective inspection and testing procedures with quality assurance engineers and cross-functional partners.
• Generate, review, and maintain quality records, including training, internal audits, NCRs, and CAPAs.
• Review lot acceptance records and device history records, enter quality data, and analyze trends.
• Support FDA and ISO 13485 inspections by gathering required information.
• Evaluate process and engineering controls to improve safety and efficiency.

Requirements

• MBO or associate degree in an engineering or scientific discipline.
• Electrical and mechanical knowledge.
• Experience in a regulated medical device industry or a biohazard/laboratory environment.
• Ability to work with QSR and ISO 13485 requirements; approximately two years of quality-related experience is preferred.
• Proficiency with Microsoft Office, especially Excel, and strong technical writing skills.
• Ability to organize and complete tasks with minimal supervision, maintain accurate records, use basic hand tools, and handle the stated physical requirements.

Nice to have

• Experience creating and analyzing charts and Pareto charts.

Culture & Benefits

• Work with a cross-functional Quality Department supporting medical device safety and compliance.
• Contribute to products designed to simplify insulin delivery for people with diabetes and other conditions.
• Performance-driven environment guided by shared values and a focus on customer expectations.