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
