Medical Device Quality Engineer — CAPA Leader & RCA

Pro Staff; Maple Grove (MN); On-site; USD 63,000 - 89,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Pet insurance

401(k) retirement plan

Employee Assistance Program

Commuter benefits

Parking

Job summary

Pro Staff in Maple Grove, MN is seeking a Quality Engineer with medical device experience to support CAPA, post-market surveillance, and continuous improvement initiatives. You will apply root-cause analysis and uphold quality operations to ensure life-changing healthcare products meet stringent standards.

Responsibilities include maintaining quality systems, authoring surveillance reports, coordinating CAPA investigations, and collaborating with manufacturing, quality, operations, and design

Qualifications

• Bachelor's degree in Engineering or related field.
• 5+ years of medical device quality engineering experience.
• 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

Regulatory compliance

Post-market surveillance

Quality engineering

Independent work

Education

Bachelor's degree in Engineering

Job description

Pro Staff in Maple Grove, MN is seeking a Quality Engineer with medical device experience to support CAPA, post-market surveillance, and continuous improvement initiatives. You will apply root-cause analysis and uphold quality operations to ensure life-changing healthcare products meet stringent standards.

Responsibilities include maintaining quality systems, authoring surveillance reports, coordinating CAPA investigations, and collaborating with manufacturing, quality, operations, and design