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Jobs via Dice · 1 day ago

Senior Quality Engineer

Irvine, CA

Full-time

Onsite

Mid, Senior Level

$90K/yr - $120K/yr

Jobot is a growing medical device company seeking a talented Senior Quality Engineer. The role focuses on sustaining engineering and ensuring compliance with quality requirements for Class II medical devices, while collaborating with various teams to support continuous improvement activities.

Computer Software

Responsibilities

Understanding of and ability to interpret and apply ISO 13485, ISO 14971, and 21 CFR Part 820, specifically design controls, purchasing controls, risk management and production and process controls

Proficiency leading CAPA investigations and supplier corrective actions

Provide expertise of our commercially launched Class II medical device product lines, with a primary focus on sustaining engineering

This role is responsible for ensuring the manufacture of high-quality medical devices by ensuring compliance with critical quality requirements

This role works closely with the Operations team to define process controls, process validation requirements and in-process inspections

This role liaisons with Design Quality, Supplier Quality, and Operations to ensure effective hand-offs and communication in support of commercial products, new products, and continuous improvement activities

The Senior Engineer will play an active role in facilitating nonconforming material report investigation and closure, failure investigations, CAPA actions, and change control activities

Qualification

ISO 13485ISO 1497121 CFR Part 820CAPA investigationsASQ Certified Quality Engineer

Required

Understanding of and ability to interpret and apply ISO 13485, ISO 14971, and 21 CFR Part 820, specifically design controls, purchasing controls, risk management and production and process controls

Proficiency leading CAPA investigations and supplier corrective actions