Senior Quality Engineer – Medical Devices

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

Benefits offered by this job

Bonus eligible (10% target)

Medical, dental, and vision coverage

401(k) match

Education reimbursement

Paid parental leave

Paid time off

Job summary

Heraeus Medevio in Minnesota is seeking a Quality Engineer III to lead diverse projects from concept to production, delivering robust quality support across the product lifecycle. You will drive continuous improvement, perform inspection and validation, and partner with suppliers to ensure compliance with medical device standards.

The role requires at least 5 years in quality assurance in the medical device sector, hands-on use of Minitab and GD&T, and strong problem-solving skills.

Qualifications

• Bachelor degree in Engineering or related technical field preferred.
• Minimum 5 years of relevant experience.
• Experience in medical device QA strongly preferred.
• Experience with gages, inspection tools, and test equipment.
• ISO 13485 and/or 9001 knowledge preferred.
• ASQ certified Quality Engineer is a plus.

Responsibilities

• Lead multiple concurrent projects from concept to production using established quality processes.
• Provide inspection development, testing, DOE, PFMEA, and GR&R support.
• Investigate nonconforming material and devise corrective actions.
• Collaborate with Supplier Quality on discrepant material.
• Use statistical tools to monitor product performance and identify improvements.
• Respond to customer complaints with failure analysis and CAPA actions.
• Document process changes and communicate with customers as needed.
• Conduct audits and close out findings with corrective actions.
• Mentor Quality and cross-functional teams.

Skills

Quality Assurance

Root cause analysis

Project Management

Statistical analysis

Six Sigma Tools

Education

Bachelor degree in Engineering or related technical field

Tools

Minitab

ERP/MRP software

GD&T

Job description

Heraeus Medevio in Minnesota is seeking a Quality Engineer III to lead diverse projects from concept to production, delivering robust quality support across the product lifecycle. You will drive continuous improvement, perform inspection and validation, and partner with suppliers to ensure compliance with medical device standards.

The role requires at least 5 years in quality assurance in the medical device sector, hands-on use of Minitab and GD&T, and strong problem-solving skills.