Job Opportunity- Analyst, Product Surveillance III - Alameda, CA -

The Fountain Group; Alameda (CA); Sur place; USD 76 000 - 81 000; Temps partiel

Résumé du poste

The Fountain Group is seeking a skilled professional for a 6-month contract in Alameda, CA, onsite only. This role focuses on independently handling complex medical device complaints, ensuring regulatory compliance, and driving data-driven improvements.

Responsibilities include leading investigations, supporting CAPA and adverse event activities, and developing dashboards and metrics to monitor quality systems. A strong regulatory background and data analytics are essential.

Qualifications

• Bachelor's degree required.
• 5–8+ years of medical device complaint handling or post-market surveillance experience.
• Strong knowledge of 21 CFR Part 820, Part 803, ISO 13485, ISO 14971, EU MDR, and related QMS.
• Experience independently evaluating, investigating, documenting, and closing complex complaints.
• Experience supporting adverse event reporting, CAPA activities, and regulatory decision making.
• Strong data analytics skills with experience analyzing large datasets.

Responsabilités

• Independently evaluate, investigate, document, and close complex medical device complaint records.
• Serve as SME for complaint handling procedures, closure decisions, and regulatory requirements.
• Support global vigilance reporting and adverse event reporting.
• Perform quality reviews of complaint files for compliance, accuracy, and data integrity.
• Analyze large complaint datasets to identify trends and drive data-based decisions.
• Develop metrics, dashboards, and tools to monitor Quality System performance.
• Utilize SQL and databases to extract and interpret complaint data.
• Support CAPA investigations, risk management, and continuous improvement.
• Author, revise, and redline complaint procedures and training materials.
• Provide guidance to complaint evaluation and closure teams and collaborate cross-functionally.

Connaissances

Medical device complaint handling

Data analytics

Regulatory knowledge

Cross-functional collaboration

Mentorship

Formation

Bachelor's degree

Outils

SQL

Databases

Description du poste

Details for the positionare as follows:

• 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

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

Required Skills:

• 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.