Quality Control/Quality Inspector - Entry Level (Onsite)

Location: Mebane, NC • Duration: 12 months • Employment type: Contract on W2 (US Citizens, GC Holders, GC EAD, OPT, EAD, or CPT only)

About the role

This entry-level position is responsible for quality inspection and quality control on manufacturing production lines, including execution of incoming inspection. Inspections cover visual, dimensional, and functional checks on a wide variety of medical-device products. The role monitors compliance to GMP and GDP, reports infractions, analyzes results, performs product sampling, verifies labels, determines product disposition, investigates root causes of nonconforming conditions, and records and reports quality data. It also drives improvements to product quality and the quality system within an established compliance framework.

Responsibilities

• Independently perform and document final inspection of production slides, vials, kits, and labels against established quality specifications; make independent acceptability determinations for release.
• Conduct incoming inspection of materials, analyze results versus specifications, and ensure correct sampling plans are followed.
• Collaborate with production associates to verify released materials, perform line verification before production starts, check documentation accuracy and completeness, and confirm equipment meets designated specifications, including calibration.
• Work with manufacturing personnel to complete required QC testing, documentation, and determine correct product disposition.
• Detect, document, and segregate nonconforming conditions to prevent further use; demonstrate bias for action to determine scope of nonconformances.
• Perform basic lab support functions: prepare standards and reagents, conduct preventive maintenance, 5S activities, and handle hazardous waste as appropriate.
• Maintain retention samples and manage electronic and physical storage of device history records.
• Adhere to gowning and PPE procedures to ensure safe work practices.
• Participate in continuous improvement activities (e.g., kaizen).
• Carry out additional responsibilities as assigned by management.

Requirements

• High School Diploma or GED with a minimum of 2 years of related QC or manufacturing experience.
• Basic knowledge of SAP is preferred.
• Experience working in an FDA-regulated environment is highly desirable.

Skills

• General proficiency in Microsoft Office (Word, Excel).
• Demonstrated understanding of sampling techniques and inspection standards.
• Basic math skills and ability to use Excel for calculations and graphing.
• Fluency in spoken and written English; ability to write technical reports and summarize information using Microsoft Word.
• Excellent attention to detail, high degree of accuracy, and ability to work independently and in team settings.
• Strong observation skills with a bias for corrective action and process improvement.
• Ability to make critical decisions regarding product quality or quality system compliance.
• Ability to assess and articulate risk when evaluating situations.
• Knowledge of basic validation, equipment calibration, and change requirements.
• Demonstrated understanding of the use of calibrated equipment.
• Proven capability to prioritize responsibilities and complete tasks on schedule.
• Ability to work independently in a fast-paced manufacturing environment.

Physical Demands

• Ability to stand for long periods of time.
• Ability to lift up to 25 lbs.
• Ability to perform repetitive motions.

Schedule

• Monday–Thursday, 7:00 AM–5:30 PM (10-hour shifts, 4 days per week).
• Schedule may flex based on business needs, including nontraditional work hours and periodic overtime as production requires.

Pay

$20–$25 per hour