Complaint Analyst

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.

Summary:

The Complaint Analyst receives complaint data from Field Representatives and Customers, enters the information into the quality system, follows up with the Field Rep or Customer to gather more information, owns and tracks a complaint through the process, and completes a final review of complaints to verify completeness before closure. This position requires experience with FDA Quality Management System Regulations and the ability to perform at high levels in a high-paced, dynamic environment.

In This Role, You Will:

• 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

Who You Will Report To:

Sr. Manager, Product Monitoring

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.

What We Offer:

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced and fun team. You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture. You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself.

We also offer an attractive compensation package, which includes:

• 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

Calyxo is deeply committed to fostering an environment where diversity and inclusion are not only valued but also prioritized. We believe a diverse and inclusive community…