Quality Engineer III

Heraeus Medevio; White Bear Lake (MN); On-site; USD 100,000 - 117,000; Full time

Job summary

Heraeus Medevio is seeking a Quality Engineer III to lead multiple projects from concept to production. You will ensure alignment with processes and customer requirements and provide quality support across the product lifecycle.

The role requires a Bachelor’s degree in engineering, 5+ years in medical device quality, and experience with ISO 13485/9001. Onsite at White Bear Lake, MN with a strong emphasis on continuous improvement and cross-functional collaboration.

Qualifications

• Bachelor's degree in Engineering or related technical field required or equivalent.
• Minimum 5 years of relevant experience in quality engineering for medical devices.
• Experience with ISO 13485 and/or 9001 standards preferred.
• ASQ Certified Quality Engineer is a plus.
• Ability to use MRP/ERP software and statistical analysis software.

Responsibilities

• Lead multiple concurrent projects from concept to production with quality focus.
• Provide quality support throughout product lifecycle including validation and nonconformance resolution.
• Drive continuous improvement and maintain compliance with quality standards.
• Act as quality interface for customer complaints and CAPA development.
• Mentor cross-functional teams in quality practices.

Skills

Gages & inspection tools & test gear

MRP/ERP software

Root cause analysis

Statistical analysis

Six Sigma tools

Geometric Dimensioning & Tolerancing

Project Management

DOE/GR&R/Minitab

Education

Bachelor's degree in Engineering or related technical field

Tools

Minitab

Job description

Together we improve lives. At Heraeus Medevio, we bring lifesaving and life-changing medical devices to market through partnerships with medical device manufacturing companies. Backed by Heraeus Group, we are committed to the growth of our teams and organization by providing an open space for open minds. To reach our vision of improving 100 million lives every year, we foster a culture of curiosity that thrives on challenge, continuous learning, growth, and the opportunity to try new things. With sites in the United States, European Union, and Asia, and over 2,200 employees worldwide, together, we will meet tomorrow's challenges today.

Position Summary

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.

What You’ll Do Every Day:

• 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.

What We’re Looking For:

• 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.
• Experience with ISO 13485 and/or 9001 standards preferred.
• ASQ certified Quality Engineer, a plus.
• Ability to utilize MRP or ERP software and Statistical Analysis software.
• Root cause analysis training, Project Management, Statistical analysis, SPC, Six Sigma Tools and Geometric Dimensioning and Tolerancing experience preferred.
• Ability to work onsite at the White Bear Lake, MN location.

Medevio is committed to providing competitive total compensation and benefits packages. The expected hiring range for this position is between $100,000 and $117,000 based upon a full-time schedule. This is a good faith estimate on the applicable range. Base salaries are determined by taking a variety of factors in account, including, but not limited to, candidate qualifications, geographic locations, market conditions and internal equity. This position is bonus eligible, with a target bonus of 10%. Our total compensation package includes eligibility for comprehensive medical, dental, and vision coverage, a 401(k) plan with company match, education reimbursement, paid parental leave and paid time off.

Heraeus is proud to be an employer that provides equal access to opportunities for all its employees. We provide fair and equal consideration to all qualified applicants, regardless of sex, gender identity, sexual orientation, race, color, religion, national origin, physical or mental disability, protected veteran status, age, or any other legally protected characteristic. A diverse and inclusive culture is at the heart of our Vision, Mission, and Values. We are dedicated to cultivating a workforce that reflects a broad spectrum of cultures, backgrounds, and perspectives.

We participate in E-Verify to confirm employment eligibility after hire. Learn more at www.e-verify.gov