Quality Manager

Bachelor's degree in a scientific, technical, or quality‑related field; advanced degree is a plus., 10+ years of hands‑on quality experience in a regulated manufacturing environment, preferably medical devices, pharma, pharma packaging, PFS, or automated injector assembly., Strong knowledge of FDA cGMP requirements (21 CFR Parts 820, 210, 211) as well as EMA regulations., Proven experience in batch record review and approval, deviation management, investigations, and CAPA leadership., Experience in leading customer audits and regulatory inspections., Solid people management experience, including training and development of quality teams., Proficiency in MS Office; experience with electronic Quality Management Systems is an advantage., Good understanding of GDP and risk‑based quality principles., Fluent English, enabling effective communication and preparation, review, and approval of quality documentation.

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