Quality Engineer I-2

About the role

The Quality Engineer I-2 supports manufacturing quality, regulatory compliance, and continuous improvement for medical device products. Reporting to senior engineers, you will ensure internal and external customer expectations are met while adhering to Integer’s values and safety standards.

Key responsibilities

• Support regulatory inspections, audits, investigations and maintain Device History Records.
• Monitor manufacturing compliance, review BOMs, assembly procedures, drawings, FMEAs and control plans.
• Participate in continuous improvement projects, product transfers and technical investigations.
• Develop and validate test methods, inspection techniques and write related procedures.
• Manage non‑conforming material disposition, lead complaint investigations and support CAPA activities.
• Assist internal quality audits and contribute to quality KPI achievement.

Required profile

• Bachelor’s degree in engineering, science or related field (or 5+ years relevant experience).
• 0‑3 years of experience in a regulated manufacturing environment.
• Awareness of domestic and international regulations and standards (FDA, ISO, QSR, UL, MDD, TGA).
• Ability to work independently and collaboratively across functional teams.

Required skills

• Microsoft Office proficiency.
• Knowledge of Quality Management Systems (QMS) and Good Documentation Practices.
• Experience with equipment, process, utility and computer system validation (IQ/OQ/PQ, CSV).
• Familiarity with root‑cause analysis, CAPA, and complaint handling.