Senior Manufacturing QA Leader – ISO 13485 & IVDR

DAKO Denmark R&D & Manufacturing; Glostrup Kommune; On-site; DKK 900,000 - 1,200,000; Full time

Benefits offered by this job

Company pension

Private health care

Medical & life insurance

Career development opportunities

Job summary

Agilent Technologies Inc. in Denmark seeks an experienced Manager to lead the Manufacturing QA Qualification and Validation team, ensuring product quality, patient safety, and regulatory compliance.

You will coordinate with Manufacturing, Regulatory Affairs, R&D and Procurement to drive strategic QA initiatives across the site. You will report to the Site QA Head Denmark and influence processes from design transfer to release, with a strong focus on audits and continuous improvement within a

Qualifications

• Master's level degree in engineering or a scientific discipline.
• At least 5 years in medical devices or pharma quality.
• Strong knowledge of ISO 13485, FDA 21 CFR part 820, MDSAP and IVDR.

Responsibilities

• Lead and develop the Manufacturing QA qualification and validation team.
• Translate business needs to team directions and objectives.
• Partner with Manufacturing to align priorities, secure resources, and enable project delivery.
• Represent QA management in strategic DK-site projects and steering groups.
• Ensure compliance with EU IVDR, ISO 13485, and Agilent QMS.
• Participate in internal and external audits as needed.
• Act as Deputy Management Representative for Site Glostrup.
• Drive continuous improvement of quality systems and documentation.
• Oversee Change Control, qualifications/validations of equipment, processes, test methods, cleaning and software.
• Monitor processes and manage risk to ensure inspection readiness.

Skills

Leadership

Quality management

Regulatory knowledge

People management

Education

MSc in Engineering or Science

Job description

Agilent Technologies Inc. in Denmark seeks an experienced Manager to lead the Manufacturing QA Qualification and Validation team, ensuring product quality, patient safety, and regulatory compliance.

You will coordinate with Manufacturing, Regulatory Affairs, R&D and Procurement to drive strategic QA initiatives across the site. You will report to the Site QA Head Denmark and influence processes from design transfer to release, with a strong focus on audits and continuous improvement within a