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Euclid Vision Corporation · 3 months ago

Senior Quality Assurance Specialist (On-Site VA)

Sterling, VA

Full-time

Onsite

Senior Level

5+ years exp

Euclid Vision Corporation is a global leader in advanced vision solutions, seeking a Senior Quality Assurance Specialist to enhance their Quality Management System. The role involves ensuring compliance with industry regulations, driving continuous improvement, and collaborating with cross-functional teams to deliver high-quality products.

EyewearHealth CareMedical

Responsibilities

Lead and support day-to-day QMS activities, ensuring compliance with 21 CFR 820 and ISO 13485

Manage complaint handling, including investigations, reportability evaluations, and return product processing

Oversee CAPA processes: conduct investigations, root cause analyses, and implement corrective actions

Review and revise procedures to meet regulatory and customer requirements

Interpret standards and regulations to develop and improve policies and processes

Support and participate in internal, supplier, and external audits; prepare and track corrective action plans

Review and approve non-conformance reports (NCRs)

Ensure data integrity and accuracy across all quality documentation

Assist in preparing reports for QMS Management Review and monthly KPI meetings

Participate in cross-functional teams focused on continuous improvement, complaints, and CAPAs

Ensure only products meeting acceptance criteria are released

Maintain and manage training records

Qualification

Quality Management System (QMS)21 CFR 820ISO 13485CAPA handlingInternal Auditor certificationEQMS platformsWritten communicationVerbal communicationOrganizational 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 with medical device complaints and CAPA handling

Proven experience supporting internal and external audits

Strong knowledge of 21 CFR 820 and ISO 13485

Outstanding written and verbal communication skills

Proficiency with Microsoft Office and eQMS platforms

Exceptional organizational and problem-solving skills; ability to manage multiple priorities