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E
Entegee
Quality Technician
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Based on Massachusetts data
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What they do
A Quality Technician inspects products to assure compliance with given standards including durability , functionality, quality, and safety.
$48,270 / year median in Massachusetts
+7% projected growth
Job Description
Job Overview We are seeking a Quality Technician with experience in the medical device industry to support returned product complaint investigations. This role is responsible for receiving, evaluating, and documenting customer complaints, performing initial root cause investigations on returned devices, and ensuring accurate technical documentation while maintaining compliance with quality system requirements. The ideal candidate will have strong technical writing skills, complaint handling experience, and a keen attention to detail. Required Qualifications Associate's degree (AA) or equivalent combination of education and relevant work experience Minimum of 1 year of related experience Previous experience performing medical device complaint investigations Experience evaluating returned devices and conducting root cause investigations Strong technical writing and documentation skills Excellent organizational and communication skills Ability to work independently while following established procedures Proficiency with Microsoft Office and quality documentation systems Preferred Qualifications Experience working in a regulated medical device manufacturing environment Familiarity with complaint management systems (GCMS or similar) Knowledge of FDA Quality System Regulations (21 CFR Part 820), ISO 13485, and Good Documentation Practices Experience with product testing and laboratory environments Key Responsibilities Receive, verify, and process returned medical device complaints. Perform initial testing and root cause investigations on returned products. Document investigation findings accurately using the complaint management system (GCMS or similar). Ensure complete product traceability throughout the complaint investigation process. Collaborate with Engineering, Manufacturing, R&D, and Customer Service to obtain information needed to complete investigations. Follow up on product returns and additional customer information when required. Prepare complaint files for final review and approval, ensuring all required documentation is complete. Maintain laboratory equipment calibration records, inventory, and documentation. Assist with maintaining and updating complaint investigation procedures and test methods. Identify opportunities to improve complaint handling processes and investigation efficiency. Maintain laboratory cleanliness and ensure compliance with company quality procedures. Support the Quality Management System by completing all required training and adhering to applicable regulatory and company quality standards. Equal Opportunity Employer/Veterans/Disabled Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria.