QC Inspector Sr Review & Release Waltham (Medtech)

TL;DR

QC Inspector Sr Review & Release Waltham (Medtech): Performing real-time quality inspections, documentation review, and final product release for reagent and consumables manufacturing with an accent on GMP, GDP, FDA-regulated quality systems, and traceable records. Focus on approving Device History Records, troubleshooting electronic transactions, resolving non-conforming materials, and training other inspectors.

Location: Onsite at the Waltham, Massachusetts facility 5 days per week, Monday through Friday. Working hours are 3:00 PM–11:30 PM.

Salary: $22.00–$29.00 per hour.

Company

hirify.global develops FDA-registered, ISO-certified instruments and biotechnology and in vitro diagnostic solutions for drug development and patient care.

What you will do

• Perform real-time inspections of reagent filling, packaging, consumables, pallets, labels, completed products, and production areas.
• Review, scan, file, and approve Device History Records, test results, documentation revisions, and product release records.
• Process finished-goods transactions and troubleshoot electronic product-release activities.
• Identify discrepancies, support non-conforming material processing, and work with engineering and manufacturing on quality issues.
• Generate and maintain product certifications and prepare Engineering Change Orders when required.
• Train Review & Release Inspectors and coordinate priorities across shifts and QC teams.

Requirements

• High school diploma or equivalent with a science concentration and 5+ years of applicable experience, including QC inspection experience; equivalent combinations of associate or undergraduate education and QC experience may be considered.
• Ability to read, write, speak, and understand English.
• Knowledge of Good Documentation Practices, GMP, GDP, QSR, FDA-regulated quality systems, and written protocols.
• Computer literacy with Microsoft Word, Excel, Access, and PowerPoint, plus data entry and data trending skills.
• Strong attention to detail, math and calculator skills, multitasking ability, and basic to advanced computer proficiency.
• Ability to collaborate effectively with QC, engineering, manufacturing, and cross-functional teams.

Culture & Benefits

• Medical, dental, and vision coverage with flexible plan options.
• Competitive 401(k) company match, bonus program, generous paid time off, and paid holidays.
• Tuition reimbursement and professional development opportunities.
• Employee engagement events and workplace food benefits, including a subsidized cafeteria at the Waltham office.
• Work in a collaborative, mission-driven organization focused on innovation, accountability, integrity, and global health.