Analyst, Product Surveillance III
About The Position
Generis Tek is recruiting an Analyst, Product Surveillance for a client in Alameda, California. This is an on-site contract role with a project duration of more than five months, a Monday-to-Friday shift from 8:00 AM to 4:30 PM, and pay of $57.00 per hour on W2. The analyst independently evaluates, investigates, documents, and closes complex medical device complaints and supports complaint handling, post-market surveillance, vigilance reporting, data analysis, and quality system activities. The role also serves as a subject matter expert for complaint procedures and regulatory requirements, provides guidance to complaint teams, and collaborates with cross-functional groups on surveillance, compliance, and improvement initiatives.
Requirements
- 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, including experience analyzing large and complex datasets to identify trends, detect emerging signals, assess risk, and support data-driven quality and regulatory decisions.
- Experience using 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.
- Strong technical writing, documentation, communication, analytical thinking, data analysis, and problem-solving skills.
Responsibilities
- Independently evaluate, investigate, document, and close complex medical device complaint records.
- Serve as a subject matter expert on complaint handling procedures, complaint closure decisions, regulatory requirements, and documentation standards.
- Support global vigilance reporting, adverse event reporting, and reportability assessments.
- Review complaint files for compliance, accurate documentation, consistency, and data integrity.
- Analyze complaint and post-market surveillance datasets to identify trends, emerging product performance signals, and risks, and to support data-driven decisions.
- Develop and maintain complaint metrics, dashboards, reporting tools, and visualizations for quality system monitoring, management reviews, regulatory compliance, and business objectives.
- Use SQL, databases, and analytical tools to extract, validate, trend, and interpret complaint data while ensuring accuracy, completeness, and integrity.
- Support CAPA investigations, risk management, signal detection, and continuous improvement 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.
- Lead or support strategic post-market surveillance initiatives, process improvement efforts, and special projects.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Career Level
Senior
Education Level
No Education Listed
