Analyst, Product Surveillance III

ManpowerGroup; Alameda (CA); On-site; USD 76,000 - 83,000; Full time

Job summary

ManpowerGroup is seeking a Product Surveillance Analyst in Alameda, CA for a 6-month onsite assignment. The role focuses on handling medical device complaints, post-market surveillance, and data-driven regulatory decisions.

The candidate will analyze large datasets, perform trend assessments, support adverse event reporting, CAPA activities, and quality metrics. Strong Excel, SQL, and eQMS experience are required for this hands-on position.

Qualifications

• 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.

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.

Skills

Medical device complaints

Data analytics

Excel proficiency

SQL proficiency

Regulatory knowledge

Technical writing

Problem solving

Tools

SQL

Salesforce

eQMS

Power BI

Job description

Title: Product Surveillance Analyst

Location: Alameda, CA (100% Onsite)

Duration: 6 Months

Shift Time: 8am to 4:30pm

Pay Range: $55/hr to $60/hr (On W2)

We are looking for a Product Surveillance Analyst to join one of our Fortune 500 clients.

Required Experience and 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.

Job 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.

We are looking for the candidate who are eligible to work with any employers without sponsorship.

ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.