About the role
Job Title: Product Surveillance Analyst II
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
- Complaint Handling & Product Surveillance
- Medical Writing & Technical Documentation
- Quality Assurance (QA)
- FDA & Global Regulatory Compliance
- CAPA & Continuous Improvement
- Cross-Functional Collaboration
- Data Analysis (Excel, Power BI)
- Root Cause Analysis
- 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
Millions of jobs, with real people getting hired every day
Questions, answered
Click "Apply with JobAssist" – we tailor your resume and application to this role and submit it for your approval.
Yes. This role at Intellectt Inc was screened before publishing – we confirmed the employer before listing it.
The employer didn't disclose a salary range for this listing. JobAssist shows pay whenever it's available.
This position can be done from anywhere, with no in-office requirement.
Yes – every application is tailored from your profile and this job's requirements, and you can review and edit before it's sent.