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Analyst, Product Surveillance III

Generis Tek Inc.
  • 🇺🇸 United States
  • On-site
  • 19 hours ago
  • CAPA
  • Data Visualization
  • Excel
  • Pivot Tables
  • Power Query
  • Data Modeling
  • SQL
  • Salesforce
  • Technical Writing
  • Regulatory Compliance
  • Risk Management
19 hours ago
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Please Contact: To discuss this amazing opportunity, reach out to our Talent Acquisition SpecialistPriyanka Mahantat email address Priyanka.mahant@generistek.com can be reached on #(630) 576-1940.
 
 
We haveContractrole Analyst, Product Surveillancefor client atAlameda, CA.Please let me know if you or any of your friends would be interested in this position.
 
Position Details:
Analyst, Product Surveillance - Alameda, CA
Location       : Alameda, CA 94502 (On-site)
Project Duration: 05+ Months of contract
Shift Timing : 8:00 AM - 4:30 PM (Mon to Fri)
Pay Rate       : $57.00 per hour on W2
 
Job Description:
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.
 
Primary Responsibilities:
  • 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.
 
To discuss this amazing opportunity, reach out to our Talent Acquisition SpecialistPriyanka Mahantat email address Priyanka.mahant@generistek.com can be reached on #(630) 576-1940.
 
 
About generis Tek: generis tek is a boutique it/professional staffing based in Chicago land. We offer both contingent labor & permanent placement services to several fortune 500 clients nationwide. Our philosophy is based on delivering long-term value and build lasting relationships with our clients, consultants and employees. Our fundamental success lies in understanding our clients’ specific needs and working very closely with our consultants to create a right fit for both sides. We aspire to be our client has most trusted business partner.
 

Analyst, Product Surveillance III · Generis Tek Inc.

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