Analyst, Product Surveillance III

Experis (Austria); Alameda (CA); On-site; USD 69,000 - 76,000; Full time

Benefits offered by this job

Medical

Dental Plan

Vision Plan

401(k)

Weekly Pay

Job summary

Our client in Alameda, CA is seeking an Analyst, Product Surveillance III to join the Quality organization. The role focuses on supporting Product Surveillance and Complaint Handling, turning data into actionable post-market insights, and ensuring regulatory compliance.

The candidate should have 5+ years in post-market surveillance within the medical device industry, with onsite presence in Alameda. 6-month duration and pay range of $50-$55/hr on W-2 are offered.

Qualifications

• 5-8 years of medical device complaint handling or post-market surveillance experience.
• Strong knowledge of 21 CFR Part 820, Complaint Files (198), 21 CFR Part 803, ISO 13485, ISO 14971, EU MDR, and medical device quality systems.
• 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.
• Advanced proficiency with Microsoft Excel (pivot tables, advanced formulas, Power Query, data modeling) and experience with SQL, databases, Salesforce, complaint handling systems, eQMS, and BI/reporting tools.

Responsibilities

• Independently evaluate, investigate, document, and close complex medical device complaint records.
• Serve as a subject matter expert for complaint handling procedures, 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 and drive data-based decisions.

Skills

Complaint handling

Post-market surveillance

Data analysis

Excel (Pivot, formulas)

SQL

Salesforce

eQMS

Regulatory knowledge (21 CFR/IP)

Tools

SQL

Salesforce

eQMS

Power Query

Bi Tools

Job description

Our client, a medical device organization is seeking a Analyst, Product Surveillance III to join their team. As a Analyst, Product Surveillance III, you will be part of the Quality organization supporting Product Surveillance and Complaint Handling teams. The ideal candidate will have a strong commitment to quality and compliance, the ability to independently investigate complex complaint records, and the drive to turn data into actionable post-market insights which will align successfully in the organization.

Job Title: Analyst, Product Surveillance III
Location: Alameda, CA - Onsite role
Duration: 6 months

Pay Range: $50-$55/hr on W2
Need a candidate with a minimum of 5 years of post-market surveillance experience within the medical device industry.

What’s the Job?

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• Independently evaluate, investigate, document, and close complex medical device complaint records. t
• Serve as a subject matter expert for complaint handling procedures, complaint closure decisions, regulatory requirements, and documentation standards. t
• Support global vigilance reporting, adverse event reporting, and reportability assessments. t
• Perform detailed quality reviews of complaint files to ensure compliance, documentation accuracy, consistency, and data integrity. t
• 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.

What’s Needed?

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• 5-8 years of medical device complaint handling or post-market surveillance experience. t
• 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. t
• Demonstrated experience independently evaluating, investigating, documenting, and closing complex medical device complaints. t
• Experience supporting adverse event reporting, complaint investigations, CAPA activities, complaint trending, risk assessments, and regulatory decision making. t
• Advanced proficiency with Microsoft Excel (pivot tables, advanced formulas, Power Query, data modeling, and data analysis techniques) and experience using SQL, databases, Salesforce, complaint handling systems, eQMS, and business intelligence/reporting tools.

What’s in it for me?

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• Opportunity to be a technical leader in complaint evaluation and closure decisions while strengthening post-market surveillance outcomes. t
• Chance to apply advanced analytics to detect emerging signals, support risk assessments, and improve proactive quality decisions. t
• Role that combines rigorous documentation with data-driven reporting to support management review and continuous improvement. t
• Collaboration across cross-functional teams including Regulatory Affairs, Medical Events, Engineering, Quality Compliance, Track & Trend, Data Analytics, and Customer Service. t
• Visibility into regulatory inspection readiness through support of internal audits, management reviews, and health authority inquiries.

Upon completion of waiting period consultants are eligible for:

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• Medical t
• Dental Plan t
• Vision Plan t
• 401(k) t
• Weekly Pay