Calyxo, Inc.
Redefining kidney stone care
Complaint Analyst
Location
United States
Posted
39 days ago
Salary
$94K - $110K / year
Bachelor Degree5 yrs expEnglish
Job Description
• Facilitate complaint investigations while ensuring completeness and consistency of complaint files/records.
• Support post-market compliance activities including handling of customer complaints in accordance with documented procedures
• Evaluate complaints and perform preliminary complaint investigation including follow up with healthcare professionals and sales representatives
• Escalate complaints when encountering new failure modes, and partner with Engineering, Field Personnel, and Quality Assurance to investigate.
• Ensure complaint documentation and records are complete in compliance with regulatory requirements
• Coordinate complaint investigation efforts with Quality and R&D team driving investigations to completion in a timely manner
• Collaborate with Customer Service, Regulatory, R&D, Manufacturing, Commercial, Medical and other functional areas to obtain/provide information related to complaint investigations and other aspects of complaint handling
• Assist in updating Quality procedures as required through the change order process.
• Maintain comprehensive records of customer interactions, complaints, and resolutions in the company's electronic Quality Management System
• Support and participate in internal and external audits
• Perform other duties as assigned by Quality Management
Job Requirements
- Education: Bachelor of Science in Engineering, Technical or Life Science discipline or equivalent work experience preferred
- Minimum 5 years of experience working in the medical device industry
- Work location: Remote
- Travel: Ability to travel up to 10%. Overnight domestic and/or international travel may be required
- Working knowledge of FDA regulation, ISO 13485 and related ISO/EN standards.
- Strategic yet hands-on when needed with a high degree of energy and drive, and the ability to seek function and process improvements continually.
- Open and direct communication style and a vision for continuous improvement and excellence.
- Experience with Class II and/or III sterile devices (preferred).
- Individual must have excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally.
Benefits
- A competitive base salary of $94,000 - $110,000 and variable incentive plan
- Stock options – ownership and a stake in growing a mission-driven company
- Employee benefits package that includes 401(k), healthcare insurance and paid vacation
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