In Process Final Inspector

Position Title: In Process & Final Inspector Work Location: Marlborough MA 01752 Assignment Duration: 6 Months Work Arrangement: Onsite Position Summary: Final Inspector 2 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 our organization'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. Key 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 as needed. • Perform other duties as assigned by leadership to meet organizational and operational needs. Qualification & Experience: • 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. • Strong attention to detail and accuracy in reviewing documentation and inspection processes. • Ability to work independently with minimal supervision and make informed decisions. • Excellent interpersonal and communication skills for effective collaboration across teams. • Thorough understanding and application of Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP). • Familiarity with quality management systems (QMS) and regulatory requirements in the medical device industry. • Ability to interpret engineering drawings, specifications, and technical documentation. • Proficient in using quality tools, metrics, and software systems, including Oracle and Agile (preferred). • Organizational skills to maintain accurate records, logs, and reports. • Commitment to continuous improvement and fostering a culture of operational excellence.. Working Conditions & Physical Demands (If Applicable): The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. • Sit; use hands or fingers, to handle or feel objects, tools, or controls. • Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl. • Lifting/pushing/pulling and carrying products weighing up to 45 pounds • Safety Shoes compliant with site specific policies/procedures must be worn in designated areas

Salary : $25