Job Title: Product Surveillance III Analyst
Work Site: Alameda, CA 94502 - Onsite
Duration: 06 Months Contract with possible extension
Shift/Schedule: M-F/ 8:00AM- 4:30 PM
Job Description:
- 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.
- Apply statistical and analytical methods to evaluate complaint trends, product performance data, surveillance indicators, and quality system metrics to support proactive quality improvements.
- Lead or support strategic post-market surveillance initiatives, process improvement efforts, and special projects.
Required Experience & Skills:
- 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.
- Experience utilizing statistical analysis, data visualization, reporting methodologies, and analytical tools to evaluate complaint data, product performance, and post-market surveillance metrics.
- Advanced proficiency with Microsoft Excel, including pivot tables, advanced formulas, Power Query, data modeling, and data analysis techniques.
- Experience working with SQL, databases, Salesforce, complaint handling systems, electronic quality management systems (eQMS), and business intelligence or reporting tools.
- Experience developing, maintaining, and interpreting quality metrics, dashboards, and performance reporting for management review and continuous improvement activities.
- Strong technical writing, documentation, communication, analytical thinking, data analysis, and problem-solving skills.