Complaint Analyst - Remote

Overview

Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment. Kidney stone disease is a common, painful condition that consumes vast amounts of healthcare resources each year. Our team is led by executives and investors with a proven track record of commercializing paradigm-shifting devices to meet unmet needs within urology.

Are you ready to change the future of kidney stone treatment? We are seeking high achievers who want to be part of a dynamic team working in a fun, diverse atmosphere.

In Short

• 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.

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.
• Full-time employment.
• 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.