The Quality Control Manager in the field of Medical Devices or Electronics Manufacturing is responsible for overseeing and managing all aspects of quality control within the organization.
This role involves ensuring that products meet established quality standards and regulatory requirements, identifying and addressing any quality issues, and implementing continuous improvement initiatives to enhance overall product quality and customer satisfaction.
Key skills:
Experience with quality control tools and methodologies, such as statistical process control (SPC), failure mode and effects analysis (FMEA), and root cause analysis (RCA) ??? BS EN ISO 14971:2021.
Familiarity with regulatory requirements and quality standards in the medical device industry, such as ISO 13485 and FDA regulations
Issuance of exception documents, such as Non-Conformances and CAPA???s
Generation of Validation and Verification documentation and testing reports.
Experience in performing Internal and External Supplier Audits.
Internal Auditor Trained