Product Quality Specialist (Temporary) at Atlantic Group

Job description

Job Overview – Product Quality Specialist (Temporary) Compensation: $40 – $45/hour (Dependent on Experience) Location: Middlesex County, MA Schedule: Monday to Friday (Hybrid) 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 will analyze post-market data, prepare surveillance reports, monitor quality metrics, and support regulatory compliance across product lines. The ideal candidate brings direct medical device or diagnostics experience with strong knowledge of complaint handling and adverse event reporting requirements. Responsibilities as the Product Quality Specialist (Temporary): • 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. Qualifications for the Product Quality Specialist (Temporary): • Education: Bachelor's degree in a scientific, technical, or related discipline is required. • Experience: 5+ years of post-market surveillance, complaint handling, quality assurance, customer support, or related medical device experience is required. • Industry Knowledge: Medical device or diagnostics experience with knowledge of ISO 13485, ISO 14971, FDA regulations, complaint handling, adverse event reporting, and post-market surveillance requirements is required. • Technical Skills: Proficiency with Microsoft Office, data analysis, quality systems, and database management is required. • Skills & Attributes: Strong analytical, technical writing, communication, problem-solving, and troubleshooting skills with the ability to collaborate effectively across quality and regulatory functions.

Requirements

Must-haves

Job Overview – Product Quality Specialist (Temporary)
Compensation: $40 – $45/hour (Dependent on Experience)
Location: Middlesex County, MA
Schedule: Monday to Friday (Hybrid)
Responsibilities as the Product Quality Specialist (Temporary):
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.
Qualifications for the Product Quality Specialist (Temporary):
Education: Bachelor's degree in a scientific, technical, or related discipline is required.
Experience: 5+ years of post-market surveillance, complaint handling, quality assurance, customer support, or related medical device experience is required.
Industry Knowledge: Medical device or diagnostics experience with knowledge of ISO 13485, ISO 14971, FDA regulations, complaint handling, adverse event reporting, and post-market surveillance requirements is required.
Technical Skills: Proficiency with Microsoft Office, data analysis, quality systems, and database management is required.
Skills & Attributes: Strong analytical, technical writing, communication, problem-solving, and troubleshooting skills with the ability to collaborate effectively across quality and regulatory functions.

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