Manager, Complaint Analyst
C
Calyxo, Inc.Medical Devices
Remote (within California)Full-TimeManager
Salary$145,000- $155,000
Apply NowOpens the employer's application page
Job Details
- Experience
- Minimum 15 years
Requirements
- Bachelor of Science in Engineering, Technical, or Life Science discipline (or equivalent experience).
- Minimum 15 years of experience in the medical device industry.
- Working knowledge of FDA 21 CFR Part 820.198 and Part 803.
- Knowledge of ISO 13485 and related ISO/EN standards.
- Experience with Class II and/or III sterile devices preferred.
- Strong verbal and written communication skills.
- Ability to travel up to 10% (domestic and/or international).
- Compliance with relevant county, state, and Federal rules regarding vaccinations.
Responsibilities
- Manage high-performing Analysts by recruiting, orienting, and developing team members.
- Lead and motivate the team by setting expectations, monitoring performance, and providing coaching.
- Create and update complaint documentation, procedures, and departmental goals.
- Facilitate complaint investigations, ensuring completeness and regulatory consistency.
- Coordinate with Quality, R&D, and other departments to resolve complaints and identify trends.
- Prepare and present metrics regarding complaint timeliness and medical device reporting.
- Participate in Quality team audits as the complaint intake subject matter expert.
- Ensure all post-market compliance activities align with 21 CFR Part 803 requirements.
View Full Description & ApplyYou'll be redirected to the employer's site
