What are the responsibilities and job description for the Quality Assurance Engineer position at Lumicity?
Join Our Team as a Quality Assurance Engineer!
We are looking for a dedicated Quality Assurance Engineer to ensure the highest quality standards in our manufacturing processes for ReValve devices. If you are passionate about quality engineering and thrive in a dynamic environment, this could be the opportunity for you!
Key Responsibilities :
- Quality Control : Design robust manufacturing processes and ensure effective controls for both in-house and supplier operations. Oversee the inspection of incoming materials, in-process components, and final products to confirm they meet design specifications.
- Design Assurance : Collaborate with a cross-functional team to lead quality engineering practices through all stages of product development, from defining design inputs / outputs to establishing test methods and inspection criteria.
- Risk Management : Engage proactively in risk assessment activities during initial product development to identify potential quality concerns and establish monitoring standards.
- Quality Management System : Champion adherence to our quality management system, ensuring compliance with established procedures and a focus on continuous improvement.
- Regulatory Compliance : Maintain thorough compliance with all regulatory standards, including FDA and ISO 13485, to ensure our products meet Good Manufacturing Practices (GMP).
- Equipment Calibration & Maintenance : Assist in the calibration and maintenance of testing and production equipment, ensuring conformity with industry standards.
- Documentation : Create and organize comprehensive documentation, including design history files and quality records, ensuring meticulous records of test results and protocols.
Qualifications :
If you meet these qualifications and are eager to contribute to high-quality medical device manufacturing, we encourage you to apply!
