Process Engineer – Medical Device & Pharma, Bilingual EN/ES

QRC Group; Caguas (PR); On-site; USD 60,000 - 80,000; Full time

Job summary

QRC Group in Caguas, Puerto Rico seeks a Process Engineer with pharma-medical device experience and validation lifecycle expertise to support daily operations. The role focuses on root-cause analysis, investigations, and CAPA closures for both manual and automated production lines.

You will work in a fast-paced manufacturing environment, coordinating across functions, and supporting 24/7 operations as needed. Bilingual English/Spanish is required for site communications.

Qualifications

• Bachelor's Degree in Engineering (Mechanical, Chemical, Industrial, Biomedical, or related field).
• Strong experience in the Medical Device industry (required).
• Pharmaceutical industry experience (preferred).
• Demonstrated experience with validation life cycle activities (design, 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.

Responsibilities

• Root cause analysis.
• Investigation experience for QN/CAPA closures.
• Experience with manual and automated systems/lines.

Skills

Process engineering

Root cause analysis

Investigations

CAPA closures

Validation lifecycle

Manufacturing operations

Education

Bachelor's degree in Engineering

Job description

QRC Group in Caguas, Puerto Rico seeks a Process Engineer with pharma-medical device experience and validation lifecycle expertise to support daily operations. The role focuses on root-cause analysis, investigations, and CAPA closures for both manual and automated production lines.

You will work in a fast-paced manufacturing environment, coordinating across functions, and supporting 24/7 operations as needed. Bilingual English/Spanish is required for site communications.