Supplier Quality Engineer I or II

Supplier Quality Engineer I or II

White Bear Lake

About Heraeus

Making displays foldable? Helping hearts beat with medical innovations? Or breathing new life into precious metals? As a family-owned global technology group we help our customers to always being one step ahead.

About Heraeus Medevio

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 Supplier Quality Engineer I oversees supplier quality activities across multiple concurrent projects, ensuring alignment with internal standards and customer requirements from supplier selection through production. The role provides comprehensive support in evaluating and developing supplier capabilities, conducting audits, managing incoming inspection processes, and resolving supplier-related nonconformances. The Supplier Quality Engineer I drives continuous improvement initiatives within the supply base, ensures compliance with regulatory and quality standards, and facilitates effective communication and documentation between suppliers and internal teams. Collaboration across departments and with external partners is essential to maintain product quality and reliability throughout the lifecycle.

The team is open to hiring at an Engineer I or II level.

What You’ll Do Every Day:

• Assess supplier suitability through evaluations, questionnaires, quality agreements, desktop and on-site audits to ensure compliance with regulatory and internal requirements.
• Partner with Procurement, Engineering, and Quality teams to qualify suppliers and support validation planning for materials and services.
• Plan, coordinate, and execute supplier desktop and on-site audits. Create annual audit plan.
• Lead investigations and coordinate cross-functional efforts to resolve supplier nonconformances. Ensure timely disposition, root cause analysis, and implementation of corrective actions.
• Provide technical guidance for inspection of purchased and customer-supplied components. Develop and refine inspection methods and sampling plans.
• Track and report supplier-related KPIs such as batch reject rates, open nonconformances, SCARs, and response times. Drive accountability and improvement through the Global Scorecard process.
• Provide primary support for the nonconforming material which includes but is not limited to disposition, investigation, corrective actions, and supplier communication.  Works closely with Quality Engineers when discrepant raw material or outside service is involved.
• Ensure timely and effective communication with suppliers to address quality concerns and foster continuous improvement.
• Maintain systems and procedures that assure compliance with quality standards/requirements.
• Evaluate and communicate supplier changes thought our CCID process. Lead internal quality activities triggered by supplier changes to ensure continued compliance and performance.
• Other duties assigned as required.

What We’re Looking For:

• Bachelor’s 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.
• Basic knowledge of engineering fundamentals.
• Experience as a Quality Engineer or Supplier Quality Engineer preferred but not required.
• Experience with supplier/internal auditing preferred.
• Experience with ISO 13485 and/or 9001 standards preferred.
• ASQ/ISO13485 certified is considered a plus.
• Ability to do local and domestic travel up to 25% of the time.

Medevio is committed to providing competitive total compensation and benefits packages. The expected hiring range for this position is between $70,000 and $92,000 based upon a full-time schedule and level of position. 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.