Quality Assurance Operations Manager

Description:

Production and operation support alongside the establishment and monitoring of process testing

Identifying improvements and inputs in the company quality plan

Control and maintain the integrity of process documentation, QMS, and regulatory requirements

Document control and engineering changes

Management of QMS processes: non-conformances (NCs), failure analysis, CAPA and SCAR

Assessment of trends in performance indicators, audits, and CAPA actions

Requirements:

Bachelor's degree in engineering or similar field

At least 10 years of experience in medical devices and knowledge of ISO13485

At least 5 years in a productive environment

Proven experience in leading a QC team and maintaining quality standards

Knowledge of FDA/EU regulations