Senior Engineer, C&Q Leader - Medical Devices/Pharma

QRC; Juncos (PR); On-site; USD 110,000 - 140,000; Full time

Job summary

QRC Group, LLC is seeking a Senior Engineer with extensive experience in Medical Devices or Pharmaceuticals to lead commissioning and qualification activities. You will define and execute C&Q strategies, manage risk assessments, and ensure regulatory compliance across GMP, FDA, and EMA requirements.

This role involves collaboration with Engineering, QA, Manufacturing, and Supply Chain. The ideal candidate holds an engineering doctorate or master's degree with relevant experience, or a bachelor's

Qualifications

• Doctorate or Masters degree with engineering experience (2+ years) or a Bachelor's degree with engineering experience (4+ years).
• Fluency in Spanish and English is required for communication with multidisciplinary teams.

Responsibilities

• Lead C&Q strategy and planning for medical devices/pharma projects.
• Coordinate commissioning activities including IQ/OQ/PQ and FAT/SAT execution.
• Review qualification protocols and ensure traceability from URS to testing.
• Ensure GMP, FDA, EMA compliance and ALCOA+ data integrity across documents.

Skills

Bilingual Spanish/English

Education

Doctorate or Masters in Engineering

Bachelor's in Engineering

Job description

QRC Group, LLC is seeking a Senior Engineer with extensive experience in Medical Devices or Pharmaceuticals to lead commissioning and qualification activities. You will define and execute C&Q strategies, manage risk assessments, and ensure regulatory compliance across GMP, FDA, and EMA requirements.

This role involves collaboration with Engineering, QA, Manufacturing, and Supply Chain. The ideal candidate holds an engineering doctorate or master's degree with relevant experience, or a bachelor's