Pay: $40/HR to $46/HR

Job Description:

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.

If selected you will guide and influence on-market product cross-functional teams through design, validation, and regulatory compliance and assure robust product vs. customer requirements. You should be able to assess manufacturing process changes and the impact to product. Must be able to formulate appropriate reasons and justifications for changes, including assessment of crucial parameters and other affected systems/products. Must possess a thorough understanding of the design control lifecycle, including design inputs, verification, validation, and commercialization.

Will maintain and ensure compliance to the quality system that is appropriate for the unit specific medical device(s) designed or manufactured. Must be able to ensure compliance to, and is able to demonstrate, knowledge of site level policies and procedures.

Qualifications:

• Bachelor's degree in Life Science, Engineering, or closely related discipline.
• Specific Skills the team is looking for: DHF, change control, and regulatory submission