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CyberCoders · 1 week ago

Senior Quality Engineer (Electrical Engineer)

Fort Lauderdale, FL

Full-time

Hybrid

Senior Level, Lead/Staff

$100K/yr - $130K/yr

8+ years exp

CyberCoders is a fast-growing medtech company revolutionizing pain management through wearable neuromodulation. As a Senior Quality Engineer, you will lead design control, supplier quality, and manufacturing efforts, ensuring compliance with ISO 13485 and FDA regulations while driving risk management initiatives.

RecruitingSearch Engine

Growth Opportunities

No H1B

Responsibilities

Lead implementation and maintenance of the Quality Management System (QMS)

Support new product development and design control compliance (DHFs, V&V protocols, risk analysis)

Drive manufacturing process validations, test method qualifications, and design changes

Manage supplier quality: audits, SCARs, NCMR investigations, and performance monitoring

Lead CAPA investigations, root cause analysis, and corrective/preventive actions

Support regulatory submissions (FDA 510(k), global) and internal/external audits (FDA, Notified Body)

Collaborate cross-functionally with Engineering, Operations, and Software teams

Analyze quality data and KPIs to drive continuous improvement initiatives

Act as Quality lead for equipment validations, change control, and document reviews

Qualification

Electrical EngineeringMedical Device Quality EngineeringISO 13485FDA 21 CFR 820Risk ManagementFMEAsStatistical AnalysisCAPALean/Six SigmaSupplier Quality ManagementCommunication SkillsDocumentation Skills