Product Monitoring Manager - Remote

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 This Role, You Will:
 
The Product Monitoring Manager is responsible for planning, assigning, and leading the team responsible for the investigation, analysis, resolution, and trending of complaints.  This includes ensuring the timely processing of complaints and adverse event reporting.  The Product Monitoring Manager works with cross functional groups such as Medical Affairs, Regulatory, Operations, Customer Service and R&D to perform all aspects of complaint investigations and complaint handling. 

Complaint Handling Process 

• Manage and maintain product complaint processes with an emphasis on continuous improvement, system effectiveness, and efficiency to meet the current and future needs of the business.
• Provide product development cycle feedback/data to reduce occurrence rates and enhance ongoing field training.
• Assist in Quality System audits with various government agencies, private companies, and consultants (such as CA FDB, US FDA, etc.), and respond to any action promptly.
• Maintain and ensure complaint files are complete and accurately reflect corresponding complaint activities.
• Partner with cross-functional departments on investigating product complaints and ensuring the timely completion and closure of complaint activities.
• Ensure efficient compliance with all applicable regulations through the implementation of a robust complaint handling system and communication/reporting to regulatory authorities.
• Lead the development of operational policies and procedures within the Complaint Management Program, and partner cross-functionally to ensure optimal processes exist to support upstream and downstream customer needs.
• Participate in Management Review meetings and assist in gathering, preparing, analyzing and presenting data to executive management on the performance of the Quality Management System.
• Develop Product Monitoring staffing plan by identifying resource requirements, writing justifications for additional personnel, obtaining approval for changes, and coordinating the selection process with Human Resources. 
• Contribute to the development and maintenance of the company's quality management system
• Implement corrective and preventive actions (CAPAs) as needed
• Analyze complex datasets to extract meaningful insights on product performance and safety
• Develop and maintain dashboards and reports to communicate product monitoring results to stakeholders
• Present findings and recommendations to senior management and cross-functional teams
• Perform other duties as assigned.  

Who You Will Report To: 

• Sr. Director, Quality

Requirements: 

• Bachelor's degree in Biomedical Engineering, Life Sciences, or related field; advanced degree preferred.
• 5+ years of experience in medical device industry, with focus on post-market surveillance or related areas
• Strong knowledge of medical device regulations and quality management systems
• Excellent analytical and problem-solving skills
• Proficiency in data analysis tools and statistical methods
• Strong communication and presentation skills
• Ability to work effectively in a cross-functional team environment.
• Education:  Bachelor of Science in Engineering, Technical, or Life Science discipline; or equivalent experience
• Minimum of 7 years experience in Complaint Management with a minimum of 5 years in the medical device industry preferred
• Excellent level of organizational skills and ability to work on several projects simultaneously with a high attention to detail
• Open and direct communication style and a vision for continuous improvement and excellence
• Experience with Class II or III sterile devices preferred
• Must be able to lift 10 pounds and occasionally lift and carry up to 25 pounts, sit for up to 8 hours/day, including daily keyboard data entry.
• Compliance with relevant county, state, and Federal rules regarding vaccinations 
• Work location:  Remote
• Travel: up to 10% travel 

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 a compensation plan as follows: 

• Competitive salary of $149,000 - $159,000
• Stock options – ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance and paid time off 

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 empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities, which strengthen our focus and fuel our growth. 
 
Calyxo is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics

Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify their identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.