Quality Assurance Specialist

Robling Medical - Youngsville, NC

Full-time - Entry Level

Youngsville, NC

Miscellaneous Manufacturing

About the position

The Quality Assurance Specialist is responsible for performing product inspections and reviewing device history records while providing support and training to manufacturing personnel. This role involves guiding manufacturing in managing nonconforming materials, conducting internal audits, and assisting with calibration programs and environmental testing.

Responsibilities

• Perform receiving inspection, in-process and/or final inspection of disposable medical devices and electro-mechanical assemblies.
• Document, control, and disposition non-conforming materials and conduct root cause analysis.
• Provide guidance and oversight to manufacturing during rework activities.
• Write nonconforming material reports and rework instructions.
• Train manufacturing employees on quality assurance processes.
• Support the QA Manager in maintaining the calibration program.
• Assist in the collection and maintenance of bioburden samples and data.
• Support Quality Engineers in testing and data collection during validation activities.
• Conduct inspections for proper machine setup.
• Perform internal audits.

Requirements

• High school graduate or equivalent.
• Strong attention to detail.
• Strong technical aptitude.
• Ability to read and understand mechanical drawings/blueprints.
• Understanding of ANSI Z1.4 sampling plans.
• Strong math skills.
• Experience with various measuring equipment (e.g., ruler, caliper, micrometer).
• Proficiency in Microsoft Word and Excel.
• Excellent written and verbal communication skills.
• Strong leadership skills.

Benefits

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance