Manufacturing QA Lead: Strategy, Compliance & Impact

DK05 DAKO Denmark R&D & Manufacturing; Glostrup Kommune; In loco; DKK 900.000 - 1.200.000; Tempo pieno

Vantaggi offerti da questo lavoro

Outstanding culture

Career development

Pension & bonus plans

Private health care

International environment

Descrizione del lavoro

Agilent Technologies Inc. in Denmark is seeking a Manager in Manufacturing QA to lead a 7-10 person team of QA engineers and specialists.

You will ensure quality and regulatory compliance across manufacturing processes for in vitro diagnostic devices and accessories used in cancer diagnostics. Reporting to the Site QA Head Denmark, Global Quality, you will drive qualification and validation, audits, and change control, while coordinating with Manufacturing, Regulatory Affairs, R&D and

Competenze

• Minimum 5 years of experience in the medical device or pharmaceutical industry.
• Strong knowledge of quality system standards (ISO 13485, FDA 21 CFR part 820, MDSAP and IVDR).
• Preferably experience with people management including hiring, coaching and performance management.

Mansioni

• Lead and develop the Manufacturing QA qualification and validation team, including talent development and performance management.
• Translate business needs to team level and set directions for the team.
• Represent QA management in strategic projects at the DK site and ensure compliance with EU IVDR and ISO 13485.
• Lead internal and external audits and act as Deputy Management Representative for Site Glostrup.
• Drive continuous improvement of systems and processes and oversee Change Control, qualification/validation of equipment, processes and methods.

Conoscenze

Team leadership

Regulatory compliance

Quality Systems

Audits

Change control

Risk management

Formazione

M.Sc. degree or equivalent

Descrizione del lavoro

Agilent Technologies Inc. in Denmark is seeking a Manager in Manufacturing QA to lead a 7-10 person team of QA engineers and specialists.

You will ensure quality and regulatory compliance across manufacturing processes for in vitro diagnostic devices and accessories used in cancer diagnostics. Reporting to the Site QA Head Denmark, Global Quality, you will drive qualification and validation, audits, and change control, while coordinating with Manufacturing, Regulatory Affairs, R&D and