Quality Engineer I‑1

About the role

Integer is seeking an entry‑level Quality Engineer to support manufacturing quality, regulatory compliance, and continuous improvement for medical device and battery products. You will work under guidance from senior engineers and managers, ensuring internal and external customer expectations are met.

Key responsibilities

• Support regulatory inspections, audits, investigations and maintain Device History Records.
• Monitor manufacturing compliance with Design Master Records, provide deviation/waiver guidance, and review changes to BOMs, drawings, specifications, FMEAs and control plans.
• Develop and validate test methods, write inspection procedures and coordinate process capability studies.
• Manage non‑conforming material disposition, lead complaint investigations and participate in CAPA activities.
• Participate in internal quality audits, continuous‑improvement projects and product transfers.

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 (ISO, QSR, FDA, UL, MDD, TGA).
• Ability to work independently and collaboratively across cross‑functional teams.

Required skills

• Proficiency with Microsoft Office.
• Knowledge of Quality Management Systems (QMS) and FDA regulations.
• Experience with validation protocols (IQ, OQ, PQ) and documentation practices.
• Familiarity with FMEA, control plans and process monitoring techniques.