Senior Quality Assurance Specialist

3 weeks ago

Sterling, United States Euclid Full time

Senior Quality Assurance SpecialistAre you passionate about quality and compliance in the medical device industry? Do you thrive in a collaborative, fast-paced environment where your expertise directly impacts patient safety and product excellence? Euclid Vision Corporation, a global leader in advanced vision solutions, is seeking a Senior Quality Assurance Specialist to join our dynamic team. At Euclid, we're dedicated to transforming lives through innovative vision care.

Our culture is built on integrity, teamwork, and continuous improvement. We offer a supportive environment where your ideas are valued, your growth is encouraged, and your work truly makes a difference. Join us and be part of a company that invests in its people and celebrates success togetherAs a Senior Quality Assurance Specialist, you'll play a key role in maintaining and enhancing our Quality Management System (QMS). You'll ensure compliance with industry regulations and standards, drive continuous improvement, and collaborate with cross-functional teams to deliver the highest quality products to our customers.

Key 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.

Qualifications

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. Internal Auditor certification preferred. 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.

What We Offer

Competitive compensation and benefits package. Opportunities for professional growth and advancement. Collaborative, inclusive, and innovative work culture. The chance to make a real impact in the lives of patients worldwide.

Ready to Make a Difference? If you're a quality-driven professional looking to join a company that values your expertise and supports your career, we want to hear from you Apply today and help us shape the future of vision care.

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