Quality Engineer III

Heraeus Group•Saint Paul, MN

5d•Onsite

About The Position

The primary responsibility of the Quality Engineer III is to lead multiple concurrent projects from concept to production, ensuring alignment with established processes and customer requirements. The role also provides comprehensive quality support throughout the product lifecycle, including inspection development, statistical analysis, validation, and nonconformance resolution. The Quality Engineer III will drive continuous improvement, maintain compliance with quality standards, and ensure timely communication and documentation of quality-related activities by collaborating across departments and with external stakeholders. This is an onsite position based out of the White Bear Lake, MN location.

Requirements

Bachelor degree in Engineering or related technical field strongly preferred; other relevant postsecondary education, training, and experience may be considered in lieu of a Bachelor’s degree.
Minimum 5 years of relevant experience required.
Experience in the medical device industry as a Quality Assurance Engineer strongly preferred.
Experience with the use and application of gages, inspection tools, and test equipment.
Ability to utilize MRP or ERP software and Statistical Analysis software.
Ability to work onsite at the White Bear Lake, MN location.

Nice To Haves

Experience with ISO 13485 and/or 9001 standards preferred.
ASQ certified Quality Engineer, a plus.
Root cause analysis training, Project Management, Statistical analysis, SPC, Six Sigma Tools and Geometric Dimensioning and Tolerancing experience preferred.

Responsibilities

Work with process development engineering through all stages of product realization process providing inspection, testing, process characterization support, correlation, DOE, PFMEA, qualifications/validations, GR&R, Minitab analysis, FAI analysis using sound statistical methods.
Provide direction and quality support for validation of production and test processes.
Provide primary support for the nonconforming material and product processes which include but are not limited to disposition, investigation, corrective actions, and customer communication.
Works closely with Supplier Quality when discrepant raw material or outside service is involved.
Utilize statistical tools to monitor and assess product performance, identify root causes, and identify process improvements.
Act as the quality interface in responding to customer complaints using failure analysis, development of corrective and preventative actions, and trend analysis.
Understands and actively works with the entire organization in the identification, evaluation, and documentation of process changes.
As applicable, communicate and process the changes with the customer.
Conducts audits, including closing out audit findings, creating audit finding reports, and determining proper corrective and preventative actions.
Provide quality support for continuous improvement projects.
Actively works within all aspects of the Quality System to provide support to the entire organization.
Provides mentorship and technical guidance to Quality and cross-functional team members, as appropriate.
Other duties may be assigned as required.