Quality Engineer - Medical Devices, CAPA & Post-Market

Advantage Technical; Maple Grove (MN); On-site; USD 45,000 - 76,000; Full time

Benefits offered by this job

Medical, dental, vision, and pet保险

401(k) Retirement Savings Plan

Employee Assistance Program (EAP)

Commuter/Parking Accounts

People Perks Program

Health Savings Account (HSA)

AD&D Insurance

Job summary

Advantage Technical in Maple Grove, MN is seeking an experienced Quality Engineer for our medical device team. The role focuses on CAPA, post-market surveillance, quality operations and continuous improvement to support life-changing healthcare products.

Responsibilities include maintaining quality systems, conducting root cause analysis, coordinating CAPA investigations, and collaborating with manufacturing, operations, design, and suppliers to ensure regulatory compliance and ongoing product

Qualifications

• Bachelor's degree in Engineering or related field.
• 5+ years medical device quality engineering experience preferred.
• Experience with post-market surveillance activities.
• Experience owning and managing CAPA processes.
• Strong root cause analysis and problem-solving skills.
• Ability to work independently and manage multiple priorities.
• Experience supporting quality systems and regulatory compliance.

Responsibilities

• Support quality systems and quality operations activities.
• Author and maintain post-market surveillance reports.
• Coordinate and manage CAPA investigations and corrective actions.
• Conduct root cause analysis and drive resolution of quality issues.
• Support design change activities and quality documentation reviews.
• Collaborate with manufacturing, quality, operations, and design teams.
• Communicate with contract manufacturers regarding quality requirements.
• Review and maintain supplier corrective action records.
• Ensure compliance with regulatory, customer, and quality system requirements.
• Identify opportunities for process improvement and quality enhancements.

Skills

CAPA management

Root cause analysis

Quality systems knowledge

Regulatory compliance

Independent work

Education

Bachelor's degree in Engineering or related field

Job description

Advantage Technical in Maple Grove, MN is seeking an experienced Quality Engineer for our medical device team. The role focuses on CAPA, post-market surveillance, quality operations and continuous improvement to support life-changing healthcare products.

Responsibilities include maintaining quality systems, conducting root cause analysis, coordinating CAPA investigations, and collaborating with manufacturing, operations, design, and suppliers to ensure regulatory compliance and ongoing product