Senior Quality Engineer, Medical Devices – Onsite

Heraeus; Saint Paul (MN); On-site; USD 100,000 - 117,000; Full time

Benefits offered by this job

401(k) plan with company match

Medical, dental, and vision coverage

Education reimbursement

Paid parental leave

Paid time off

Job summary

Heraeus Medevio in White Bear Lake, MN, is seeking a Quality Engineer III to lead multiple concurrent projects from concept to production, ensuring compliance with ISO standards and customer requirements.

You will provide quality support across the product lifecycle, develop inspections, perform statistical analyses, and drive continuous improvement with cross-functional teams. Onsite role with strong emphasis on documentation, audits, and remediation of nonconformances.

Qualifications

• Bachelor degree in Engineering or related technical field preferred.
• Minimum 5 years of relevant experience in quality engineering.
• Experience in the medical device industry preferred.
• Experience with gages, inspection tools, and test equipment.
• ISO 13485 and/or 9001 knowledge preferred.
• ASQ CQE certification a plus.

Responsibilities

• Lead multiple concurrent projects from concept to production.
• Provide QA support across the product lifecycle, including inspection development and validation.
• Manage nonconformance resolution, CAPAs, and customer communications.
• Collaborate with Supplier Quality on material and service issues.
• Use statistics to monitor product performance and drive improvements.
• Conduct audits and close out findings with corrective actions.
• Mentor team members and support cross-functional initiatives.

Skills

Quality engineering

Root cause analysis

Statistical analysis

Project management

Continuous improvement

Education

Bachelor degree in Engineering or related field

Tools

Minitab

MRP/ERP software

Inspection tools

Job description

Heraeus Medevio in White Bear Lake, MN, is seeking a Quality Engineer III to lead multiple concurrent projects from concept to production, ensuring compliance with ISO standards and customer requirements.

You will provide quality support across the product lifecycle, develop inspections, perform statistical analyses, and drive continuous improvement with cross-functional teams. Onsite role with strong emphasis on documentation, audits, and remediation of nonconformances.