Process Engineers

QRC Group, LLCCaguas, PR
Onsite

About The Position

We are seeking a Process Engineer to support daily manufacturing operations for a leading medical device environment. The ideal candidate will bring strong technical expertise in process engineering, validations, investigations, and continuous improvement within regulated industries.

Requirements

  • Bachelor's Degree in Engineering (Mechanical, Chemical, Industrial, Biomedical, or related field).
  • Strong experience in the Medical Device industry (required).
  • Demonstrated experience with validation activities (write, execute, analyze, and close protocols/reports).
  • Experience performing root cause analysis and implementing solutions.
  • Experience leading and supporting investigations, QN, and CAPA closures.
  • Experience working with manual and automated manufacturing systems/production lines.
  • Ability to work effectively in a fast-paced manufacturing environment.
  • Bilingual (English and Spanish) required.
  • Availability to work in Texas.

Nice To Haves

  • Pharmaceutical industry experience (preferred).

Responsibilities

  • Support daily manufacturing and process operations.
  • Lead and participate in process validations, including: Protocol development, Execution, Data analysis, Final report generation and closure
  • Conduct root cause investigations and implement corrective actions.
  • Support Quality Notifications (QN) and CAPA investigations through closure.
  • Troubleshoot manufacturing issues affecting product quality, yield, and efficiency.
  • Collaborate with cross-functional teams including Quality, Manufacturing, Validation, and Engineering.
  • Provide technical support for both manual and automated production systems.
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