Validation Engineer - Top Medical Device Company

JOB DESCRIPTION

Insight Global is looking for a Senior Quality Engineer to lead process verification and validation activities across multiple product families. This role oversees inspection planning, supports quality reviews, drives troubleshooting and deviation investigations, and partners with cross‑functional teams including global sites like Costa Rica to ensure smooth design transfer, risk management, and compliance. The Senior QE will contribute to test method development, risk‑based decision‑making, business improvement initiatives, and timely escalation of project risks, with occasional travel required.

REQUIRED SKILLS AND EXPERIENCE

• A minimum of 4 years of experience in Supply Chain, Quality and/or R&D within a GMP or ISO regulated industry

• Excellent problem solving and decision-making skills

• Experience conducting Process Verification / Validation including IQ / OQ / PQ, TMV and creation of other validation documents such as URS

• Experience leading risk management activities and developing associated documentation, such as Failure Modes & Effects Analysis

• Interpersonal skills that foster collaboration as it relates to technical situations

• Strong initiative and follow-through in completing project responsibilities, overcoming obstacles and balancing multiple priorities effectively through strong technical and/or project leadership experience

NICE TO HAVE SKILLS AND EXPERIENCE

• Other Advanced degree or a degree with a focus in Engineering, Science, Computer Science, or Digital area

• Quality Engineering experience

• Experience with CNC Machining

• Experience with inspection & test methods including GD&T

• Experience working with MES systems and associated Quality process flows