Quality Engineer II – Med Device, Validation & CAPA

Integer Holdings Corporation; Quakertown (Bucks County); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Medical, dental, vision, disability, &

401(k) with company matching

Parental leave

Paid holidays

Training & development

Job summary

Integer Holdings Corporation is seeking a Quality Engineer to apply advanced quality tools in the medical device industry. You will resolve complex problems, adhere to QMS and FDA requirements, and support inspections, audits, and process improvements.

You will collaborate with manufacturing and engineering teams, review documentation, and contribute to CAPA activities while maintaining a strong focus on quality and regulatory compliance.

Qualifications

• Bachelor's degree in engineering or related field required; 3 years' relevant experience.
• Alternative: 7+ years of relevant experience if education requirement not met.
• Awareness of ISO, QSR and FDA regulations is preferred.
• Strong written and oral communication skills.

Responsibilities

• Lead generation and completion of protocols and reports for test method validations.
• Interface with Manufacturing Engineers to review processes and coordinate validations.
• Review BOM changes, assembly procedures and component specifications for accuracy.
• Participate in CAPA activities, data analysis, and root-cause investigations.
• Support regulatory inspections, audits, and compliance with QMS and safety requirements.

Skills

Written and oral communications

Technical aptitude

Problem solving

Collaboration

Education

Bachelor's degree in engineering or related field

7+ years relevant experience if education not met

Tools

Microsoft Office

Job description

Integer Holdings Corporation is seeking a Quality Engineer to apply advanced quality tools in the medical device industry. You will resolve complex problems, adhere to QMS and FDA requirements, and support inspections, audits, and process improvements.

You will collaborate with manufacturing and engineering teams, review documentation, and contribute to CAPA activities while maintaining a strong focus on quality and regulatory compliance.