Quality Engineer III

Heraeus is a family-owned global technology group helping customers stay one step ahead through innovations in displays, medical devices, and precious metals. Heraeus Medevio, a division of Heraeus Group, partners with medical device manufacturers to bring lifesaving and life-changing devices to market. With over 2,200 employees across the United States, European Union, and Asia, we foster a culture of curiosity, continuous learning, and growth to improve 100 million lives every year.

About the role

The Quality Engineer III leads multiple concurrent projects from concept to production, ensuring alignment with established processes and customer requirements. This role provides comprehensive quality support throughout the product lifecycle, including inspection development, statistical analysis, validation, and nonconformance resolution. The position drives continuous improvement, maintains compliance with quality standards, and ensures timely communication and documentation of quality-related activities through collaboration across departments and with external stakeholders. This is an onsite position based in White Bear Lake, MN.

Responsibilities

• Work with process development engineering through all stages of the product realization process, providing inspection, testing, process characterization support, correlation, DOE, PFMEA, qualifications/validations, GR&R, Minitab analysis, and FAI analysis using sound statistical methods.
• Provide direction and quality support for validation of production and test processes.
• Support nonconforming material and product processes, including disposition, investigation, corrective actions, and customer communication. Collaborate with Supplier Quality for discrepant raw material or outside services.
• Utilize statistical tools to monitor and assess product performance, identify root causes, and drive process improvements.
• Act as the quality interface for customer complaints, using failure analysis, corrective and preventive actions, and trend analysis.
• Identify, evaluate, and document process changes, communicating them to customers as applicable.
• Conduct audits, close out audit findings, create reports, and determine corrective and preventive actions.
• Provide quality support for continuous improvement projects.
• Support all aspects of the Quality System across the organization.
• Mentor and provide technical guidance to Quality and cross-functional team members.
• Perform other duties as assigned.

Requirements

• Bachelor’s degree in Engineering or a related technical field strongly preferred; other relevant postsecondary education, training, and experience may be considered.
• Minimum of 5 years of relevant experience required.
• Experience in the medical device industry as a Quality Assurance Engineer strongly preferred.
• Experience with gages, inspection tools, and test equipment.
• Familiarity with ISO 13485 and/or ISO 9001 standards preferred.
• ASQ Certified Quality Engineer certification is a plus.
• Proficiency in MRP or ERP software and statistical analysis software.
• Experience with root cause analysis, project management, statistical process control (SPC), Six Sigma tools, and Geometric Dimensioning and Tolerancing (GD&T) preferred.
• Ability to work onsite at the White Bear Lake, MN location.

Pay

The expected hiring range for this full-time position is $100,000 to $117,000, determined by candidate qualifications, geographic location, market conditions, and internal equity. This role is bonus-eligible with a target bonus of 10%.

Benefits

• Comprehensive medical, dental, and vision coverage.
• 401(k) plan with company match.
• Education reimbursement.
• Paid parental leave.
• Paid time off.