Quality Engineer ~ GMP

Join to apply for the Quality Engineer I ~ GMP role at Inte Pros
. We’re actively seeking qualified candidates for this position.

• Experience in a medical device or pharmaceutical environment.
• Experience with Good Manufacturing Practices (GMP) and regulatory compliance.
• Experience with root cause analysis.

• On Site
• Entry Level (0-5 years experience)
• Full-time
• Quality Assurance
• Industries: IT Services and IT Consulting

• Conduct root cause analysis and implement corrective and preventive actions (CAPAs) for process deviations and non-conformances.
• Collaborate with cross-functional teams, including manufacturing, R&D, and regulatory affairs, to enhance product quality and process efficiency.
• Participate in risk management activities, such as Failure Modes and Effects Analysis (FMEA) for equipment and tooling.
• Support complaint investigations by analyzing lot history records and manufacturing processes.
• Support the development and execution of manufacturing change implementation plans.
• Ensure adherence to FDA, ISO 13485, and other relevant regulatory and quality system requirements.
• Document and analyze quality data to drive process improvements and operational excellence.

• Must Have:
  • Bachelor’s Degree in Biomedical Engineering, Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or related field.
• Nice to Have:
  • Internship or co‑op experience in a medical device, pharmaceutical, or manufacturing environment.
  • Knowledge of Six Sigma, Lean Manufacturing, and process improvement methodologies.
  • Experience with Good Manufacturing Practices (GMP) and regulatory compliance.
  • Strong analytical and problem‑solving skills.
  • Ability to work collaboratively in a team environment.
  • Basic knowledge of quality systems, statistical analysis, and process validation.
  • Effective communication skills for documentation, reporting, and cross‑functional collaboration.