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Senior Quality Assurance Specialist
Euclid Vision Corporation
- United States
- United States
About
Senior Quality Assurance Specialist
role at
Euclid Vision Corporation Join a Leader in Vision Innovation! Are 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. Why Euclid Vision Corporation
At Euclid, were 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 together. About the Role
As a Senior Quality Assurance Specialist (Complaints), youll play a key role in maintaining and enhancing our Quality Management System (QMS). Youll 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 Manage complaint handling, including investigations, reportability evaluations, and return product processes Review and approve non?conformance reports (NCRs) Lead and support day?to?day QMS activities, ensuring compliance with 21 CFR 820 and ISO 13485 Oversee CAPA processes: conduct investigations, root cause analyses, and implement corrective action Review and revise procedures to meet regulatory and customer requirements Interpret standards and regulations to develop and improve policies and procedures Support and participate in internal, supplier, and external audits; prepare and track corrective action plans 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 CAPA Ensure only products meeting acceptance criteria are released Maintain and manage training records
Qualifications
Bachelors 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 youre 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. Job Details Seniority level: Mid?Senior level Employment type: Full?time Job function: Quality Assurance Industry: Medical Equipment Manufacturing
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Languages
- English
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