Quality Specialist

Miejsce pracy: Warszawa

Recruitment for

A global well known organisation in innovative solutions and advanced technologies across the medical and life sciences.

Provide training on quality standards and foster a culture of quality awareness across teams.
Manage and improve the QMS in line with ISO 9001:2015, ISO 13485:2016, and local regulations.
Organize and conduct internal and external audits (ensuring preparation, follow-up, and the execution of corrective actions).
Oversee the creation, maintenance, and compliance of quality-related documentation such as SOPs and inspection records.
Oversee investigations into quality issues, identify root causes, and implement effective CAPA initiatives to ensure continual improvement.
Monitor and evaluate suppliers to ensure adherence to high-quality standards.
Work closely with various departments, including Regulatory Affairs and Sales, to embed quality into every aspect of operations.

Proven expertise in quality management, with a strong grasp of ISO 9001:2015 and ISO 13485:2016 standards.
Experience with QMS and auditing processes.
Bachelors or Masters degree in a related field.
Strong problem-solving, and organizational skills.
Proficiency in English and MS Office tools.
Ability to manage multiple tasks and perform under pressure.
Valid drivers license.