Own complaint handling, vigilance reporting, nonconformance, CAPA, and post-market surveillance (PMS) processes end-to-end: intake, triage, investigation, root cause analysis (RCA) using structured methods (e.g., 5-Whys, fishbone, etc.), documentation, timely closure, and reporting/trending. Define and run quality KPIs and trending dashboards, identify signals, drive cross-functional follow-up actions, update DHF documents.
Maintain and continuously improve the Quality Management System (QMS) and Security/Privacy Policies in compliance with ISO 13485, FDA 21 CFR Part 11/820, IEC 62304, EU MDR, HIPAA and other relevant regulations/standards: author/revise SOPs and Work Instructions (WIs), create practical templates/checklists, and ensure processes are followed.
Partner with Director RAQA, Engineering, Product, and Clinical to ensure DHF documentation (design controls & risk management) meets regulatory requirements.
Deliver effective training across the organization (role-based, practical, and measurable), and track training compliance.
Drive audit readiness: prepare for internal and external audits, coordinate responses, and own remediation/closure of audit findings with objective evidence.

Requirements

BS in Engineering, Data Science or related analytical discipline.
4–6 years of Quality experience in the medical device industry
Strong knowledge of ISO 13485, ISO 14971, IEC 62304 and FDA QSR/21 CFR Part 820; practical experience running DHF creation, complaints, NC/CAPA.
Demonstrated ability to write and improve SOPs/WIs and create clear objective evidence for audits.
Strong organizational and communication skills.
Demonstrated ability to operate independently, prioritize competing needs, and drive closure across teams in a fast-paced environment.
Experience with SaMD/CDSS product software lifecycle quality (e.g., traceability, verification/validation evidence, risk controls).
Hands-on experience implementing or operating an eQMS (document/change control, training, CAPA/complaints, design & risk controls).
Experience supporting post-market surveillance trending and dashboards (e.g., Excel/Sheets, Tableau, or similar).
Knowledge of cybersecurity and electronic protected health information (ePHI) processes. This includes working knowledge of HITRUST, SOC2, HIPAA, and/or GDPR.
CQE/CQA or Lean Six Sigma training/certification.

Benefits

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Applicant Tracking System Keywords

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Hard Skills & Tools

complaint handlingvigilance reportingnonconformanceCAPApost-market surveillanceroot cause analysisquality KPIsDHF documentationSOPsrisk management

Soft Skills

organizational skillscommunication skillsindependent operationprioritizationcross-functional collaborationtraining deliveryaudit readinessproblem-solving

Certifications

CQECQALean Six Sigma