Quality Engineer (Medical Devices)

Location: Prelouc, Czech Republic; hybrid working model with up to 2 days of home office per week

Company

hirify.global develops and manufactures engineered components and subsystems for medical devices, robotics, advanced manufacturing, and other mission-critical applications.

What you will do

• Lead and coordinate quality and validation activities for production transfers and manufacturing changes.
• Create, review, and approve validation plans, protocols, reports, process control plans, and controlled documentation.
• Participate in process, equipment, and manufacturing validations in controlled manufacturing and cleanroom environments.
• Assess the impact of manufacturing changes on validation status and support implementation.
• Prepare and review PFMEA and other risk management documentation.
• Support internal, customer, and certification audits, root-cause investigations, and continuous improvement activities.

Requirements

• Experience in a regulated manufacturing environment, such as medical devices, pharmaceuticals, biotechnology, or food supplements.
• Hands-on experience with validation activities and controlled documentation.
• Knowledge of ISO 13485, ISO 9001, GMP, or similar quality standards and regulations.
• Experience in cleanroom or controlled manufacturing environments is highly desirable.
• Ability to work independently and collaborate effectively with cross-functional teams.
• Fluent Czech and English required.

Culture & Benefits

• Flexible working hours and hybrid work with up to 2 home-office days per week.
• 25 days of annual leave.
• Free lunches and transportation allowance.
• Company contribution to pension savings and an Edenred benefits card.
• Annual salary review based on performance.
• International projects and collaboration across global sites.