Complaint Handling Specialist
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Job Location:
Alameda, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
18 hours ago
Vacancies:
1 Vacancy
Job Summary
Role: Complaint Handling Specialist
Location - Alameda CA
Job Description:
- 10 years of Complaint handling experience in Medical Devices domain.
- Experience in managing complete complaint handling workflows from Intake Evaluation Regulatory Assessment Investigation Reporting Closure Trending
- Collaborate with Manufacturing Quality R&D and IT stakeholders to map end-to-end Complaint handling processes and identify optimization opportunities through AI automation
- Solid understanding of complaint management systems investigation processes and regulatory expectations.
- Support data flow design system integration across Complaint handling DHF DMR/DHR systems.
- Ensure solution design and implementation comply with regulatory cybersecurity and data integrity requirements (21 CFR Part 11 ISO 13485 GxP).
- Developing dashboards or reports based on data flowing out from Complaint handling systems for supporting decision making.
- Good Project management experience
- Education: Bachelor or Masters degree in Biomedical Engineering Information Systems Computer Science or a related discipline.
- Excellent analytical problem-solving skills.
- Strong communication and stakeholder management capabilities across multi-functional teams.
Key Skills
- Sales Experience
- Crane
- Customer Service
- Communication skills
- Heavy Equipment Operation
- Microsoft Word
- Case Management
- OSHA
- Team Management
- Catheterization
- Microsoft Outlook Calendar
- EHS
