Senior Injection Molding Validation Specialist

QRC Group, LLC; Cidra (PR); On-site; USD 80,000 - 110,000; Full time

Job summary

QRC Group, LLC in Cidra, Puerto Rico seeks a Validation Specialist to support development, execution and documentation of validation activities for molds and equipment, including IQ, OQ and PQ phases. The role involves creating and updating SOPs, ensuring compliance with project plans, and developing inspection programs for tooling and parts.

Requirements include a Bachelor in Science, 5+ years in an FDA-regulated setting, strong technical writing, and fluent English and Spanish communication to

Qualifications

• Bachelor in Science degree required.
• Experience in FDA-regulated industry (5+ years).
• Proven experience performing validation lifecycle activities.
• Strong technical writing and documentation skills.
• Read, write, speak English and Spanish fluently.

Responsibilities

• Plan, execute, and document validation lifecycle activities (IQ/OQ/PQ).
• Develop inspection programs for tooling and part setup.
• Update SOPs and ensure compliance with Product Development Plans.
• Prepare protocols, tests, and reports with traceability.

Skills

IQ/OQ/PQ validation

Gage R&R

Metrology tools

Technical writing

Bilingual EN/ES

Education

Bachelor in Science

Tools

CMM

Calipers

Micrometers

Vision inspection systems

Gage R&R methods

Job description

QRC Group, LLC in Cidra, Puerto Rico seeks a Validation Specialist to support development, execution and documentation of validation activities for molds and equipment, including IQ, OQ and PQ phases. The role involves creating and updating SOPs, ensuring compliance with project plans, and developing inspection programs for tooling and parts.

Requirements include a Bachelor in Science, 5+ years in an FDA-regulated setting, strong technical writing, and fluent English and Spanish communication to