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?
\t- 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?
\t- 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?
\t- 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:
\t- Medical \t
- Dental Plan \t
- Vision Plan \t
- 401(k) \t
- Weekly Pay
If this is a role that interests you and you\'d like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!
About ManpowerGroup, Parent Company of: Manpower, Experis, Talent Solutions, and Jefferson Wells.
ManpowerGroup (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands ? Manpower, Experis, Talent Solutions, and Jefferson Wells ?creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2023 ManpowerGroup was named one of the World\'s Most Ethical Companies for the 14th year - all confirming our position as the brand of choice for in-demand talent.
