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Quality Assurance Complaints Specialist
2 weeks ago
Are you passionate about quality and compliance in the medical device industry? Euclid Vision Corporation is seeking a hands-on, detail-oriented Quality Specialist to join our team In this critical role, you'll be the primary owner of our complaints handling process, ensuring we meet the highest standards for quality and regulatory compliance.
What You'll Do:
- 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.
What We're Looking For:
- 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.
Why Join Us?
At Euclid Vision Corporation, you'll play a key role in ensuring the safety and satisfaction of our customers while advancing your career in a collaborative, fast-paced environment. If you're ready to make an impact and grow with a leader in the medical device industry, we want to hear from you
