Senior Engineer, Regulatory & Manufacturing Compliance

QRC Group, LLC; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

QRC Group, LLC in Juncos, Puerto Rico is seeking a Senior Engineer to support FDA/regulatory commitments, manufacturing-floor investigations, root cause analysis, deviation investigations, and CAPA development and implementation.

You will prepare technical reports and engineering assessments, review equipment histories and specifications, and collaborate with Manufacturing, Quality, Validation, and external vendors to deliver traceable, inspection-ready conclusions based on robust evidence.

Qualifications

• Bachelor's in Engineering with 4+ years of experience required.
• Experience preparing technical reports, engineering assessments, and justifications.
• Knowledge of cGMP and regulatory commitments preferred.

Responsibilities

• Prepare, review, and approve technical reports and engineering assessments.
• Evaluate equipment failures, performance history, and potential impact on product quality.
• Provide technical support for deviations, CAPAs, change controls, and risk assessments.
• Assess equipment design, lifecycle, maintenance strategies, and fitness for use.
• Review drawings, vendor docs, manuals, calibration records, and data history.
• Collaborate with Manufacturing, Quality, Validation, and vendors to obtain technical information.

Skills

Technical report writing

Cross-functional collaboration

Problem solving

Strong communication

Education

Bachelor's degree in Engineering

Job description

QRC Group, LLC in Juncos, Puerto Rico is seeking a Senior Engineer to support FDA/regulatory commitments, manufacturing-floor investigations, root cause analysis, deviation investigations, and CAPA development and implementation.

You will prepare technical reports and engineering assessments, review equipment histories and specifications, and collaborate with Manufacturing, Quality, Validation, and external vendors to deliver traceable, inspection-ready conclusions based on robust evidence.