Product Surveillance Analyst

Location:
Burlington, MA

Duration: 12 Months

Job Summary

We are seeking an experienced Analyst, Product Surveillance II (Senior Quality Specialist) to support quality and product surveillance activities within a regulated healthcare environment. The ideal candidate will have expertise in complaint handling, regulatory compliance, medical writing, and quality systems while collaborating with cross-functional teams to ensure product quality, regulatory adherence, and continuous process improvement.

Key Responsibilities

• Manage product complaint handling and quality surveillance activities.
• Prepare clear, accurate medical and quality documentation.
• Ensure compliance with FDA, ISO, and global regulatory requirements.
• Analyze quality data using Excel, Power BI, and related reporting tools.
• Collaborate with cross-functional teams to resolve quality issues.
• Lead or support quality improvement initiatives and assigned projects.
• Identify process improvements and implement corrective actions.
• Provide guidance to QA team members or contractors when required.
• Contribute to project planning, execution, and quality deliverables.
• Support organizational quality objectives and regulatory inspections.

Skills Required

• Medical Writing & Technical Documentation
• Quality Assurance (QA)
• FDA & Global Regulatory Compliance
• Cross-Functional Collaboration
• Data Analysis (Excel, Power BI)
• Quality Management Systems (QMS)
• Healthcare/Medical Device Industry Experience
• Strong Communication & Problem-Solving Skills
• Bachelor's Degree in Life Sciences, Engineering, or related field
• 4+ years of Quality or related experience, preferably in the healthcare or medical device industry