Quality Manager

Dodano 16/04/2026

Global company in the medical sector
Jelcz

O naszym kliencie

A growing organisation within the life science industry. Company is committed to delivering high-quality products and solutions. It operates within a collaborative environment, focusing on innovation and regulatory compliance to meet client needs.

Opis stanowiska

Develop and implement quality management systems in line with industry standards and regulations.
Oversee quality assurance activities, including audits, inspections, and corrective actions.
Ensure compliance with regulatory requirements specific to the life science industry.
Collaborate with the engineering and manufacturing teams to improve processes and reduce defects.
Lead the investigation and resolution of quality issues, ensuring root cause analysis and preventive measures.
Provide training and support to staff on quality standards and practices.
Maintain documentation and records related to quality compliance and certifications.
Work closely with suppliers to ensure quality standards are upheld throughout the supply chain.

Profil kandydata

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.