What are the responsibilities and job description for the Senior Quality Assurance Specialist position 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, 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 together
!
About the Ro
leAs a Senior Quality Assurance Specialist (Complaints), 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 customer
s.
Key Responsibiliti
- es:Manage complaint handling, including investigations, reportability evaluations, and return product processi
- ng.Review and approve non-conformance reports (NCR
- s).Lead and support day-to-day QMS activities, ensuring compliance with 21 CFR 820 and ISO 134
- 85.Oversee CAPA processes: conduct investigations, root cause analyses, and implement corrective actio
- ns.Review and revise procedures to meet regulatory and customer requiremen
- ts.Interpret standards and regulations to develop and improve policies and process
- es.Support and participate in internal, supplier, and external audits; prepare and track corrective action pla
- ns.Ensure data integrity and accuracy across all quality documentati
- on.Assist in preparing reports for QMS Management Review and monthly KPI meetin
- gs.Participate in cross-functional teams focused on continuous improvement, complaints, and CAP
- As.Ensure only products meeting acceptance criteria are releas
- ed.Maintain and manage training recor
ds.
Qualificati
- ons:Bachelor’s degree or at least 5 years of experience in quality/regulatory roles within a regulated environment (medical device, pharma, biotech, or life scienc
- es).Minimum 5 years of hands-on experience with medical device complaints and CAPA handl
- ing.Internal Auditor certification prefer
- red.Proven experience supporting internal and external aud
- its.Strong knowledge of 21 CFR 820 and ISO 13
- 485.Outstanding written and verbal communication ski
- lls.Proficiency with Microsoft Office and eQMS platfo
- rms.Exceptional organizational and problem-solving skills; ability to manage multiple priorit
ies.
What We O
- ffer:Competitive compensation and benefits pac
- kage.Opportunities for professional growth and advance
- ment.Collaborative, inclusive, and innovative work cul
- ture.The chance to make a real impact in the lives of patients world
wide.
Ready to Make a Diffe
rence?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