Senior Quality Engineer – Medical Devices

Integer Holdings Corporation; Salem (VA); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

Life and disability insurance

401(k) with company matching

Paid holidays and PTO

Job summary

Integer Holdings Corporation is seeking a Quality Engineer to apply general engineering methods within our medical device quality systems. You will use advanced quality tools under guidance to help meet FDA regulations, drive CAPA, and support inspections.

The role emphasizes process improvement, change control, and collaboration across manufacturing and QA teams, with a focus on device history records, BOM reviews, and validation activities.

Qualifications

• Bachelor's degree in engineering or related field (3+ years experience acceptable per policy).
• Awareness of ISO, QSR, UL, MDD, TGA and related standards.
• Strong written and verbal communication skills.
• Ability to work independently in a fast-paced production environment.

Responsibilities

• Perform general engineering tasks and apply quality tools in medical device context.
• Develop test methods, protocols and validation reports.
• Support regulatory inspections, audits, CAPA, and investigations.
• Review BOMs, assembly procedures, drawings, FMEAs, and control plans.

Skills

Technical aptitude

Written and verbal communication

Independence

Cross-functional collaboration

Education

Bachelor's degree in engineering or related field

Tools

Microsoft Office

Job description

Integer Holdings Corporation is seeking a Quality Engineer to apply general engineering methods within our medical device quality systems. You will use advanced quality tools under guidance to help meet FDA regulations, drive CAPA, and support inspections.

The role emphasizes process improvement, change control, and collaboration across manufacturing and QA teams, with a focus on device history records, BOM reviews, and validation activities.