Quality Assurance Specialist

$37,440 - $45,760/Yr

Volt - Youngsville, NC

Full-time

Youngsville, NC

Administrative and Support Services

About the position

The Quality Assurance Specialist role at Volt involves ensuring the quality and compliance of disposable medical devices and electro-mechanical assemblies through various inspection and documentation processes. The position requires a detail-oriented individual who can perform inspections, manage non-conforming materials, and support manufacturing activities while adhering to established quality standards.

Responsibilities

• Perform receiving, in-process, and/or final inspections of purchased and customer owned parts for disposable medical devices and electro-mechanical assemblies.
• Perform activities related to the documentation, control, disposition and root cause analysis of the non-conforming material.
• Perform review of Device History Records and other documentation for compliance to established procedures and Good Documentation Practices.
• Provide assistance, guidance, and oversight of manufacturing in the execution of rework activities.
• Accurately document the results of the inspections and testing.
• Maintain all controlled document files and test records in a timely and accurate manner.
• Maintain a thorough understanding of individual component specifications, blueprints, and sampling plans.
• Write accurate and detailed nonconforming material reports.
• Communicate discrepancies or concerns with various suppliers and initiate follow-up on Supplier Corrective Action Preventive Action requests.
• Conduct and document roving process, equipment set-up, and system audits using written procedures as audit standards.
• Monitor critical equipment and instrumentation to ensure proper operation and calibration.
• Provide support to Quality Engineers in the testing and data collection during execution of validation activities.

Requirements

• High School diploma or General Education Degree (GED) and applicable experience with at least 3 years of experience in the field.
• Excellent High School math skills.
• Experience with various measuring equipment (i.e., ruler, caliper, micrometer, visual measuring equipment).
• Ability to understand ANSI Z1.4 Sampling Plans.
• Ability to read and understand mechanical drawings and blueprints.
• Proficient computer skills (MS Word, Excel, PowerPoint, Outlook).
• Strong analytical skills and attention to detail.

Benefits

• Benefits will be provided by the employer as this is a Direct Hire role.