Product Quality Specialist (Temporary)

Job ID #50075 – Temporary role in Middlesex County, MA.

About the role

Atlantic Group is hiring a Product Quality Specialist (Temporary) to support post-market surveillance, complaint handling, regulatory reporting, and quality system compliance within a medical-device environment. This role will analyze post-market data, prepare surveillance reports, monitor quality metrics, and support regulatory compliance across product lines.

Responsibilities

• Compile and analyze post-production quality data; prepare surveillance reports and monitor product-performance trends.
• Support complaint-handling processes, ensuring investigations, documentation, and follow-up activities meet quality requirements.
• Evaluate and support medical-device and adverse-event reporting in accordance with applicable regulatory requirements.
• Monitor quality metrics, KPIs, and risk indicators to identify trends, process gaps, and opportunities for improvement.
• Develop and update quality procedures, documentation, and surveillance processes within a regulated environment.
• Partner with regulatory, engineering, manufacturing, quality, and technical teams to resolve product-quality and compliance issues.

Requirements

• Bachelor’s degree in a scientific, technical, or related discipline.
• 5+ years of post-market surveillance, complaint handling, quality assurance, customer support, or related medical-device experience.
• Medical-device or diagnostics experience with knowledge of ISO 13485, ISO 14971, FDA regulations, complaint handling, adverse-event reporting, and post-market surveillance requirements.
• Proficiency with Microsoft Office, data analysis, quality systems, and database management.

Skills

• Strong analytical, technical-writing, communication, problem-solving, and troubleshooting skills.
• Ability to collaborate effectively across quality and regulatory functions.

Pay

$40 – $45/hour (dependent on experience).

Schedule

Monday to Friday (hybrid).