[Hiring] Complaint Analyst Manager @Calyxo

Role Description

The Complaint Analyst Manager is responsible for planning, assigning, and leading the team responsible for the complaint intake, follow-ups, and final complaint review, 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 Investigators, Medical Affairs, Regulatory, Operations, Customer Service, and R&D to perform all aspects of handling.

In This Role, You Will:

• Manage high-performing Analysts by recruiting, selecting, orientating, and developing team member growth.
• Lead and motivate a high-performing team by communicating job expectations, developing action plans, monitoring and appraising work performance, coaching and counseling team members.
• Complete check-ins and annual performance reviews.
• Manage, create and update goals for direct reports.
• Participate and lead Propel Validations and updates.
• Create and update complaint documentation and procedures.
• Train new team members on proper complaint intake, follow-ups, reviews, and closures.
• Train team members on new processes.
• Recommend and implement changes in complaint processes.
• Review the accuracy of team member complaints and communicate changes as needed.
• Participate in Quality team audits as the complaint intake SME.
• Facilitate complaint investigations while ensuring completeness and consistency of complaint files/records, and participate in generating reports for complaint data, metrics, and trends.
• Support all post-market compliance activities including handling of customer complaints and medical device reporting in accordance with 21 CFR Part 803 Medical Device Reporting.
• 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.
• Review Literature and Articles submitted by other departments to identify potential complaints.
• 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.
• Prepare and present metrics related to the Complaint Handling process including complaint timeliness, as reported and as investigated events, and medical device reporting.
• Collaborate with Customer Service, Regulatory, R&D, Manufacturing, Commercial 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.
• Perform other duties as assigned by Quality Management.

Qualifications

• Bachelor of Science in Engineering, Technical or Life Science discipline; or equivalent work experience preferred.
• Minimum 15 years of experience working in the medical device industry.
• Working knowledge of FDA 21 CFR part 820.198 and part 803, ISO 13485 and related ISO/EN standards.
• 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.
• Compliance with relevant county, state, and Federal rules regarding vaccinations.

Requirements

• Ability to travel up to 10%. Overnight domestic and/or international travel may be required.
• 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.

Benefits

• Competitive base salary range of $145,000 - $155,000.
• Stock options – ownership and a stake in growing a mission-driven company.
• Employee benefits package that includes 401(k), healthcare insurance, and paid vacation.