Senior C&Q Engineer - Medical Devices & Pharma

QRC Group, LLC; Juncos (PR); On-site; USD 90,000 - 150,000; Full time

Job summary

QRC Group, LLC in Juncos, Puerto Rico seeks a Senior Engineer experienced in Medical Devices or Pharma to lead commissioning and qualification activities. You will define system boundaries, develop IQ/OQ/PQ plans, and coordinate with vendors to ensure compliant, validated systems.

Position entails leading documentation, risk assessments, CAPAs, and change controls, with cross-functional interaction among Engineering, QA, Manufacturing, and Supply Chain teams.

Qualifications

• Doctorate or Masters in Engineering with 2+ years of engineering experience.
• Bachelors in Engineering with 4+ years of engineering experience.

Responsibilities

• Develop and implement the overall Commissioning & Qualification strategy aligned with project and regulatory requirements.
• Define system boundaries and identify direct/indirect impact systems.
• Develop C&Q plans, schedules, and resource forecasting.
• Oversee and/or execute commissioning activities including FAT, SAT, and field commissioning.
• Ensure systems are installed and operate per design specifications.
• Coordinate with vendors and contractors during startup activities.
• Review and approve commissioning documentation and test results.

Education

Doctorate or Masters in Engineering

Bachelors in Engineering

Job description

QRC Group, LLC in Juncos, Puerto Rico seeks a Senior Engineer experienced in Medical Devices or Pharma to lead commissioning and qualification activities. You will define system boundaries, develop IQ/OQ/PQ plans, and coordinate with vendors to ensure compliant, validated systems.

Position entails leading documentation, risk assessments, CAPAs, and change controls, with cross-functional interaction among Engineering, QA, Manufacturing, and Supply Chain teams.