QC Coordinator (Medtech)

TL;DR

QC Coordinator (Medtech): Reviewing Device History Records (DHRs) and ensuring compliance for IAB Pumps and Spare Parts with an accent on GDP and regulatory standards. Focus on auditing documentation for accuracy, authorizing product release, and coordinating with cross-functional teams to resolve discrepancies.

Location: Onsite in Wayne, NJ

Salary: $32.00 - $35.00 per hour

Company

hirify.global provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows in intensive care, cardiovascular procedures, and sterile reprocessing.

What you will do

• Review Device History Records (DHRs) and data collection sheets for IAB Pumps and Spare Parts to ensure completeness and compliance.
• Verify that all manufacturing, inspection, testing, and documentation requirements are properly recorded.
• Ensure Good Documentation Practices (GDP) compliance, reviewing entries for accuracy, legibility, and traceability.
• Coordinate with Manufacturing and Quality teams to identify and resolve documentation discrepancies before product release.
• Authorize the release of materials and pumps upon successful completion of DHR verification.
• Provide day-to-day guidance and training to QC Inspectors to promote consistency across the department.

Requirements

• 3 years of experience in Quality, Manufacturing, Documentation Review, or QA within a regulated environment.
• Experience reviewing Device History Records (DHRs), batch records, or manufacturing documentation.
• Knowledge of Good Documentation Practices (GDP) in medical devices, pharmaceutical, or other regulated industries.
• Proficiency with TrackWise, SAPME, SAP, and Microsoft Office products.
• High School diploma required; some college preferred.
• Must be located in Wayne, NJ (site-based role).

Culture & Benefits

• Comprehensive Health, Dental, and Vision insurance.
• 401k plan with company match.
• Paid Time Off, Parental, and Caregiver Leave.
• Tuition Reimbursement and wellness initiatives.
• Commuter benefits and Health Assistance Resources.