Quality Assurance Engineer II - Medical Devices

Integer Holdings Corporation; Salem (AL); On-site; USD 80,000 - 120,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

Life insurance

401(k) with company match

Paid time off

Job summary

Integer Holdings Corporation is seeking a Quality Engineer to perform general engineering duties while applying advanced quality tools in the medical device industry. You will ensure compliance with FDA/QSR, support inspections, manage non-conforming materials, and drive process improvements across manufacturing.

The role emphasizes collaboration with cross-functional teams, document control, and development of test methods, with a focus on maintaining high quality and regulatory compliance.

Qualifications

• Bachelor's degree in engineering or related field, plus relevant experience.
• ISO, QSR, FDA regulations knowledge required.
• CAPA, deviation and change control experience preferred.
• Strong communication and teamwork skills necessary.

Responsibilities

• Support regulatory inspections, audits, investigations and inquiries.
• Monitor manufacturing for compliance and maintain Device History Records.
• Review changes to BOMs, procedures, drawings, and specifications.
• Lead test method protocol development and validation activities.
• Disposition of non-conforming materials and corrective actions.
• Support internal quality audits and quality KPI attainment.
• Contribute to continuous improvement and site quality initiatives.

Skills

Quality engineering

Regulatory knowledge

Root cause analysis

Document control

Education

Bachelor's degree in engineering or related field

Tools

Microsoft Office

Job description

Integer Holdings Corporation is seeking a Quality Engineer to perform general engineering duties while applying advanced quality tools in the medical device industry. You will ensure compliance with FDA/QSR, support inspections, manage non-conforming materials, and drive process improvements across manufacturing.

The role emphasizes collaboration with cross-functional teams, document control, and development of test methods, with a focus on maintaining high quality and regulatory compliance.