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Analyst, Product Surveillance III - Alameda, CA
Job in
Alameda, Alameda County, California, 94501, USA
Listed on 2026-10-22
Listing for:
The Fountain Group
Full Time
position Listed on 2026-10-22
Job specializations:
-
Quality Assurance - QA/QC
Data Analyst
Job Description & How to Apply Below
- 6-month contract to start with the possibility of extension or conversion depending on performance and business needs
- Rate: $55-59 an hour
- Location:
Alameda, CA
-100% onsite
- Independently evaluate, investigate, document, and close complex medical device complaint records.
- Serve as a subject matter expert for complaint handling procedures, complaint closure decisions, regulatory requirements, and documentation standards.
- Support global vigilance reporting, adverse event reporting, and reportability assessments.
- Perform detailed quality reviews of complaint files to ensure compliance, documentation accuracy, consistency, and data integrity.
- Analyze large complaint and post-market surveillance datasets to identify trends, detect emerging product performance signals, support risk assessments, and drive data-based decision making.
- Develop and maintain complaint metrics, dashboards, reporting tools, and visualizations to support Quality System monitoring, management review activities, regulatory compliance, and business objectives.
- Utilize SQL, databases, and analytical tools to extract, validate, trend, and interpret complaint data while ensuring data accuracy, completeness, and integrity.
- Support CAPA investigations, risk management activities, signal detection, and continuous improvement initiatives through data analysis and trend evaluation.
- Author, revise, and redline complaint handling procedures, work instructions, forms, templates, and training materials.
- Provide guidance, mentorship, and technical support to complaint evaluation and closure teams.
- Support regulatory inspections, internal audits, management reviews, and health authority inquiries.
- Collaborate with Regulatory Affairs, Medical Events, Engineering, Quality Compliance, Track & Trend, Data Analytics, Customer Service, and other cross-functional teams
- Bachelors degree required
- 5-8+ years of medical device complaint handling or post-market surveillance experience.
- Strong working knowledge of 21 CFR Part 820, Complaint Files (198), 21 CFR Part 803, ISO 13485, ISO 14971, EU MDR, and medical device quality systems.
- Demonstrated experience independently evaluating, investigating, documenting, and closing complex medical device complaints.
- Experience supporting adverse event reporting, complaint investigations, CAPA activities, complaint trending, risk assessments, and regulatory decision making.
- Strong data analytics skills with demonstrated experience analyzing large and complex datasets to identify trends, detect emerging signals, assess risk, and support data-driven quality and regulatory decisions.
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