Quality Assurance Manager
1 day ago
The Quality Assurance Manager is responsible for ensuring the quality and regulatory compliance of medical devices throughout the manufacturing process.
This role involves developing and implementing quality assurance strategies, overseeing production processes, managing product quality, and ensuring adherence to industry standards and regulations.
- Develop, implement, and maintain quality assurance plans, procedures, and control measures.
- Monitor and analyze production processes to detect and resolve quality issues.
- Ensure compliance with relevant regulatory requirements, including FDA, ISO 13485, and other applicable standards.
- Support internal and external audits and regulatory inspections.
- Investigate and resolve product-related issues, deviations, and non-conformities, with the authority to recommend corrective and preventive actions.
This includes support for new product transfers and ensuring that products meet specifications.
The Quality Assurance Manager will also be responsible for maintaining comprehensive records of quality control activities, inspection results, and non-conformance reports.
Requirements- Degree in Engineering or Science, with 2-5 years of progressive quality responsibility, preferably in medical device/pharmaceutical manufacturing.
- Knowledge of regulatory requirements and quality standards, including FDA regulations and ISO 13485 standards.
- Good command of the English language.
- Strong analytical and problem-solving skills with the ability to troubleshoot complex issues.
- Effective collaboration with cross-functional teams and clear presentation of information.
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