What are the responsibilities and job description for the Quality Engineer position at Alexander Technology Group?
The Alexander Technology Group is looking for a Quality Engineer with expertise in medical products. The ideal candidate will ensure compliance with regulatory standards and drive continuous improvement in product quality and safety.
This is a fully on-site position
Full-time / perm
NO 3rd party c2c applicants will be considered
Key Responsibilities :
- Quality Management : Develop, implement, and maintain quality assurance processes and systems for combination medical products.
- Regulatory Compliance : Ensure compliance with FDA, ISO 13485, cGMP and other relevant regulations and standards.
- Risk Management : Conduct risk assessments and implement risk management strategies throughout the product lifecycle.
- Testing and Validation : Oversee testing protocols, validation processes, and ensure thorough documentation of results.
- Root Cause Analysis : Lead investigations into product quality issues, performing root cause analysis and implementing corrective actions.
If interested, please send resume to Jpolombo@alexandertg.com
