Product Quality Specialist: Post-Market & Regulatory Hybrid

Atlantic Group; Massachusetts; Hybrid; USD 55,000 - 62,000; Full time

Job summary

Atlantic Group is hiring a Product Quality Specialist (Temporary) in Middlesex County, MA for our client, supporting post-market surveillance, complaint handling, regulatory reporting, and quality system compliance within a medical device environment. This role requires experience in medical device quality systems and cross-functional collaboration.

The ideal candidate will analyze post-market data, prepare surveillance reports, monitor quality metrics, and assist with regulatory reporting to

Qualifications

• Post-market surveillance and data analysis in a medical device environment.
• Handle complaints with investigations and documentation.
• Support regulatory reporting per applicable requirements.
• Ensure quality system compliance across product lines.

Responsibilities

• Post-Market Surveillance: Compile and analyze post-production quality data while preparing surveillance reports and monitoring product performance trends.
• Complaint Management: Support complaint handling processes and ensure investigations, documentation, and follow-up activities meet quality requirements.
• Regulatory Reporting: Evaluate and support medical device and adverse event reporting in accordance with applicable regulatory requirements.
• Quality Analytics: Monitor quality metrics, KPIs, and risk indicators to identify trends, process gaps, and opportunities for improvement.
• Quality Procedures: Develop and update quality procedures, documentation, and surveillance processes within a regulated environment.
• Cross-Functional Support: Partner with regulatory, engineering, manufacturing, quality, and technical teams to resolve product quality and compliance issues.

Skills

Analytical skills

Technical writing

Communication

Problem solving

Troubleshooting

Education

Bachelor's degree

Tools

Microsoft Office

Data analysis

Quality systems

Database management

Job description

Atlantic Group is hiring a Product Quality Specialist (Temporary) in Middlesex County, MA for our client, supporting post-market surveillance, complaint handling, regulatory reporting, and quality system compliance within a medical device environment. This role requires experience in medical device quality systems and cross-functional collaboration.

The ideal candidate will analyze post-market data, prepare surveillance reports, monitor quality metrics, and assist with regulatory reporting to