Senior Quality Assurance Engineer Job Description
We are seeking a highly skilled Senior Quality Assurance Engineer to join our team. This role will play a critical part in ensuring the quality of our products and services, from design to delivery.
About the Role:
* Sustain commercial projects from a Design Assurance perspective
* Support the introduction/implementation of product/process/materials changes to the manufacturing operation
* Assess patient risk appropriately for these design changes
* Provide QA technical direction/input to qualification and validation activities in conjunction with R&D and Mfg. Engineering
Responsibilities:
Key Responsibilities:
1. Design or specify inspection and testing mechanisms and equipment; conduct quality assurance tests; and perform statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications
2. Ensure that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements
3. Collaborate with engineering and manufacturing functions to ensure quality standards are in place
Requirements:
Main Requirements:
* Level 8 Engineering Degree
* 4+ years Experience in Quality/ Design Assurance/ R&D Engineering in the Medical Device Industry
* Experience with risk management, change management with product process changing, material changing, design validation protocol, work cross functional teams
Benefits:
We offer a competitive salary package, excellent benefits, and opportunities for professional growth and development.