QC Technician II (Medical Device)

TL;DR

QC Technician II (Medical Device): Performing acceptance testing and inspection of in-process and finished goods to ensure compliance with established requirements with an accent on FDA regulations and patient safety. Focus on executing functional tests, reviewing shop floor paperwork, and monitoring Statistical Process Control (SPC) data to prevent defects.

Location: Onsite in Wayne, NJ, US

Salary: $27/hr - $29/hr plus overtime

Company

hirify.global provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows.

What you will do

• Perform functional acceptance testing and inspections on assembled products per approved procedures.
• Review Shop Floor Paperwork (SFP) for accuracy and completeness prior to product release.
• Manage non-conforming materials through the NCMR process.
• Document test results, inspections, and maintain quality records.
• Train inspectors on testing methods, applicable procedures, and new policies.
• Monitor and trend SPC data to identify process instability and escalate risks to management.

Requirements

• High school diploma or equivalent (Associate or Bachelor's degree in science, Math, or Business preferred).
• Minimum of 2 years of experience in a quality function or regulated environment.
• Experience in an FDA-regulated environment (medical device experience strongly preferred).
• Ability to perform basic math and accurate measurements.
• Proficiency with SAP and Microsoft Office Products.

Nice to have

• Certified Quality Technician (CQT) certification.
• Prior Instron testing experience (Series IX, Merlin, or Blue Hill).

Culture & Benefits

• Focus on personal and professional development within diverse teams.
• Mission-driven environment focused on making life-saving technology accessible.
• Collaborative team culture with an emphasis on quality and patient safety.
• Reasonable accommodations provided during the selection process.