Highlights
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. 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.
Numbers & Facts
| Location | Alameda, CA |
| Industry | Staffing/Employment Agencies |
| Salary | $50–$55.50 Per Hour |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | http://www.lancesoft.com/ |
Description
Title: Product Surveillance Analyst III
Location:Alameda, CA 94502
Duration: 5+ Months, End date is 04/11/2027
Description:
Required Experience & Skills
Primary Responsibilities
Location:Alameda, CA 94502
Duration: 5+ Months, End date is 04/11/2027
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.
About Company
We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.