Quality Control Inspector 2

Hologic Careers • Marlborough, MA

92d • $46,100 - $69,000

About The Position

The Quality Control Inspector is a critical member of the Quality Assurance team, responsible for ensuring that finished products and in-process components meet all regulatory, quality, and customer requirements before release to inventory. This role involves the meticulous review of Device History Records (DHRs), performing inspections, and providing support to manufacturing and quality processes, such as Incoming Inspection, Material Review Board (MRB), Calibration and Returned Material Authorization (RMA) activities. The Final Inspector 2 is instrumental in upholding Hologic’s commitment to excellence by ensuring compliance with Good Manufacturing Practices (GMP), ISO standards, and quality systems, while fostering a culture of continuous improvement and collaboration.

Requirements

• High school degree and/or an equivalent technical school education preferred.
• Minimum of 3 to 5 years related Quality Inspection experience in Medical Manufacturing environment.
• Experience with Oracle and Agile preferred.

Responsibilities

• Perform detailed reviews of Device History Records (DHRs) as part of final inspection and release activities for finished products, ensuring accuracy and compliance with documentation standards.
• Conduct reviews of manufacturing records for replacement components, subassemblies, and in-process inspections to ensure alignment with quality requirements.
• Support manufacturing personnel by ensuring proper documentation of Failure Investigation Reports and processing of Non-Conforming Materials in the Product Lifecycle Management (PLM) system, including identification, quarantine, and documentation.
• Perform routine inspections, including field service and special inspections, to support validations, studies, and incoming inspection activities.
• Communicate and reinforce Good Manufacturing Practices (GMP) to manufacturing personnel to uphold quality standards.
• Review and provide input on new releases of Inspection and Test documents to ensure adherence to Good Documentation Practices (GDP).
• Maintain QA Activity Collection Plans, First Pass Yield reports, and other applicable tracking mechanisms to monitor quality metrics.
• Collaborate with Engineering to provide feedback on documentation improvements and process changes.
• Support Incoming, product returns and calibration teams as needed.
• Perform other duties as assigned by leadership to meet organizational and operational needs.

Benefits

• Annualized base salary range of $46,100-$69,000, bonus eligible.

What This Job Offers

• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees