Senior C&Q Engineer, Medical Devices

QRC Group; Juncos (PR); On-site; USD 120,000 - 180,000; Full time

Job summary

QRC Group in Juncos, Puerto Rico is seeking a Senior Engineer with experience in Medical Devices or Pharma. You will lead commissioning and qualification activities to ensure systems meet design and regulatory requirements.

Duties include developing C&Q strategies, defining system boundaries, executing IQ/OQ/PQ, and coordinating with vendors. You will mentor junior engineers and document results in GMP-compliant records.

Qualifications

• PhD or MSc with 2+ years engineering experience or a BS with 4+ years.
• Strong understanding of GMP/FDA/EMA standards relevant to medical devices.
• Experience in commissioning, validation, and data integrity practices.

Responsibilities

• Develop and implement Commissioning & Qualification strategy aligned with project and regulatory needs.
• Define system boundaries and identify affected systems.
• Create C&Q plans, schedules and resource forecasts.
• Oversee commissioning activities including FAT, SAT, field commissioning.
• Ensure installed systems operate per design specifications and approve test results.
• Coordinate with vendors and contractors during startup activities.
• Review and approve qualification protocols and maintain traceability from URS to testing.
• Support risk assessments, change controls, and CAPAs related to qualification.

Skills

Engineering experience

Regulatory knowledge

GMP/FDA understanding

Education

Doctorate in Engineering

Master's in Engineering

Bachelor's in Engineering

Tools

IQ/OQ/PQ protocols

Qualification execution

Job description

QRC Group in Juncos, Puerto Rico is seeking a Senior Engineer with experience in Medical Devices or Pharma. You will lead commissioning and qualification activities to ensure systems meet design and regulatory requirements.

Duties include developing C&Q strategies, defining system boundaries, executing IQ/OQ/PQ, and coordinating with vendors. You will mentor junior engineers and document results in GMP-compliant records.