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Euclid Vision Corporation · 3 months ago

Quality Assurance Complaints Specialist

Sterling, VA

Full-time

Onsite

Senior Level

5+ years exp

Euclid Vision Corporation is seeking a hands-on, detail-oriented Quality Specialist to join their team in the medical device industry. In this critical role, you will lead the complaints handling process, ensuring compliance with regulatory standards and collaborating with cross-functional teams to drive improvements.

EyewearHealth CareMedical

Responsibilities

Lead the end-to-end complaints handling process: review, assess, document, investigate, and close complaints in a timely and compliant manner

Analyze complaint data, conduct root cause analysis, and collaborate with cross-functional teams (Quality Assurance, Regulatory Affairs, Operations) to resolve issues and drive improvements

Monitor complaint trends and escalate reportable events as needed

Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and other applicable regulations

Support internal and external audits, and participate in CAPA (Corrective and Preventive Action) activities

Review and revise procedures to maintain regulatory compliance and meet customer requirements

Assist with non-conformance reviews, management review meetings, and KPI reporting

Qualification

Complaint handling21 CFR 820ISO 13485Regulatory complianceEQMS systemsCommunication skillsOrganizational skillsProblem-solving skills

Required

Bachelor's degree OR at least 5 years of experience in quality/regulatory roles within a regulated environment (medical device, pharma, biotech, or life sciences)

Minimum 5 years of hands-on experience in medical device complaint handling

Proven experience supporting audits and delivering accurate regulatory/quality deliverables

Strong knowledge of 21 CFR 820 and ISO 13485

Excellent communication skills (written and verbal)

Proficiency with Microsoft Office and electronic QMS (eQMS) systems

Exceptional organizational and problem-solving skills, with the ability to manage multiple priorities