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Validation Engineer at Anord Mardix - ApplyBlast

Validation Engineer

Anord Mardix

4 months ago

Buffalo Grove, Illinois

Onsite

Full Time

Senior

0 applicants

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About this role

A Validation Engineer at Flex supports engineering teams in medical device manufacturing by ensuring equipment and processes are qualified to meet internal policies and regulatory requirements. The role involves leading qualification activities, authoring validation protocols (IQ/OQ/PMV/PQ), managing audits, and implementing validation controls across manufacturing areas. Candidates must have extensive experience in validation processes, risk management, and medical device regulations within a collaborative environment.

Responsibilities

Lead process validation and qualification activities for medical device manufacturing
Author and execute validation plans, protocols, and summary reports
Manage regulatory compliance agency and customer audits as subject matter expert
Implement validation controls for manufacturing areas to ensure regulatory compliance
Perform risk assessments and manage changes to existing quality system processes

Skills

Qualifications

Bachelor's degree in engineering or sciences6 years of validation experience4 years in medical device or pharmaceutical industryCFR Part 820 and ISO 13485 knowledge4 years of injection molding experience