QA Manager Site Denmark, Global Quality (Medical Devices)

Location: Glostrup, Denmark

Company

hirify.global develops and manufactures in vitro diagnostic medical devices and accessories, including products used in cancer diagnostics.

What you will do

• Lead and develop a team of 7–10 QA engineers and specialists in qualification and validation.
• Translate business objectives into team priorities, allocate capacity, and manage succession planning.
• Partner with Manufacturing, Regulatory Affairs, Research and Development, and Procurement on product design transfer, manufacturing changes, and product release.
• Represent QA management in strategic projects and project steering groups at the Glostrup site.
• Oversee qualifications and validations for equipment, processes, test methods, cleaning, and software.
• Drive continuous improvement, change control, process monitoring, risk management, and audit readiness.

Requirements

• M.Sc. or equivalent university degree in Engineering or a scientific discipline.
• At least 5 years of experience in the medical device or pharmaceutical industry.
• Strong knowledge of ISO 13485, FDA 21 CFR Part 820, MDSAP, and IVDR.
• Experience with people management, including hiring, coaching, and performance management, is preferred.
• Ability to lead internal and external audits and ensure compliance with hirify.global's quality management system.

Culture & Benefits

• International organization with a dynamic working environment.
• Career development opportunities.
• Company pension scheme and individual bonus plan.
• Private healthcare, medical insurance, and life insurance.
• Occasional travel and a daytime work schedule.

Hiring process

• Applications are reviewed continuously.
• Submit a CV and cover letter through the recruitment system.