What are the responsibilities and job description for the Medical Device Quality Engineer position at Intellectt Inc?
Summary:
The Quality Engineer, Quality Assurance will be responsible for supporting cross functional teams through changes to on-market product design and manufacturing processes. Additionally, the candidate may provide support for other design and compliance projects within the division.
Design Control:
- The candidate will guide and influence on-market product cross-functional teams through design, validation, and regulatory compliance and assure robust product vs. customer requirements.
- The candidate should be able to assess manufacturing process changes and the impact to product.
- They should be able to formulate appropriate reasons and justifications for changes, including assessment of crucial parameters and other affected systems/products.
- They should possess a thorough understanding of the design control lifecycle, including design inputs, verification, validation, and commercialization.
- Knowledge of application of IVDR standards to the design process a plus.
Quality System:
- The candidate maintains and ensures compliance to the quality system that is appropriate for the unit specific medical device(s) designed or manufactured.
- They must be able to ensure compliance to, and is able to demonstrate, knowledge of site level policies and procedures.
Education:
- Bachelor's degree in Life Science, Engineering, or closely related discipline.
- At least 5 years work experience in Quality or related field experience in Medical Devices.
