Quality Engineer II — Medical Devices & CAPA

Integer Holdings; Quakertown (Bucks County); On-site; USD 80,000 - 110,000; Full time

Job summary

Integer Holdings is seeking a Quality Engineer to apply advanced quality tools in the medical device sector. You will ensure compliance with FDA regulations and internal QMS while supporting inspections, CAPA, and continuous improvement initiatives.

You will review design and manufacturing controls, validate processes, and collaborate with manufacturing, engineering and QA teams to prevent defects and enhance product quality.

Qualifications

• Bachelor's degree in engineering or related field; 3 years of relevant experience, or 7+ years if no degree.
• Awareness of ISO, QSR, UL, MDD, TGA and related regulatory standards.
• Proficient in Microsoft Office and data analysis tools.

Responsibilities

• Adhere to Quality Management System (QMS), FDA regulations, and site policies.
• Support regulatory inspections, audits, investigations and CAPA activities.
• Review changes to BOMs, assembly procedures, drawings and control plans.
• Lead test method validations, protocol development and reporting.
• Disposition non-conforming materials and manage corrective actions to prevent recurrence.
• Participate in site quality activities and drive continuous improvement.
• Collaborate with cross-functional teams to improve product and process quality.

Skills

Quality mindset

Problem solving

Team collaboration

Written and oral communication

Regulatory knowledge

Education

Bachelor's degree in Engineering or related field

Tools

Microsoft Office

Job description

Integer Holdings is seeking a Quality Engineer to apply advanced quality tools in the medical device sector. You will ensure compliance with FDA regulations and internal QMS while supporting inspections, CAPA, and continuous improvement initiatives.

You will review design and manufacturing controls, validate processes, and collaborate with manufacturing, engineering and QA teams to prevent defects and enhance product quality.