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.
General: The candidate must be able to provide solutions to a wide range of difficult problems, while ensuring that those solutions are compliant, innovative, thorough, practical and consistent with organizational objectives.
They will serve as the QA team member on cross-functional project teams; must be able to interact effectively with employees, manager, and cross-functional peers.
They must be able to communicate confidently and effectively with management, peers, and key stakeholders.
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 on the 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 is 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 be 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 (diagnostic quality, technical area, etc); Less experience may be appropriate with an advanced degree.
Preferred experience in the Healthcare industry; preferred experience with instrument systems and associated software.