Quality Control/Quality Inspector - Entry Level

Location: Mebane, NC • Duration: 12 months • Pay rate: $20–25/hr • 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, samples products, verifies labels, determines product disposition, investigates root causes of nonconformities, and records and reports quality data. The position also supports continuous improvement of product quality and the quality system.

Responsibilities

• Independently perform and document final inspection of all production slides, vials, kits, and labels to established quality specifications; make independent determination of acceptability for release.
• Independently perform incoming inspection of a wide variety of materials, analyze inspection results versus specifications, and ensure correct sampling plans are used.
• Work with production associates to ensure released materials are correctly accounted for, line verification is performed prior to production start, documentation is accurate and complete, and equipment meets designated specifications including calibration.
• Work with manufacturing personnel to complete required QC testing, documentation, and determine correct disposition.
• Detect nonconforming conditions during inspection, accurately document each condition, determine scope of nonconformities, and segregate nonconforming products to prevent further use.
• Perform basic lab support functions: preparation of basic standards and reagents, preventive maintenance, 5S, and cleaning and handling of hazardous waste as appropriate.
• Maintain retention samples and electronic and physical storage of device history records.
• Perform work in a safe manner adhering to gowning and PPE procedures.
• Participate in continuous improvement activities (e.g., kaizen).
• Additional responsibilities as assigned by management.

Requirements

• High School Diploma or GED with a minimum of 2 years 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.
• Demonstrated understanding of sampling techniques and inspection standards.
• Basic math skills and ability to use Excel for calculations and graphing.
• Ability to speak, read, and write English fluently; write technical summaries and data reports using Microsoft Word.
• Excellent attention to detail with a high degree of accuracy; ability to work independently and in team situations.
• Strong observation skills with a bias for corrective action and process improvement.
• Demonstrated 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 25 lbs.
• Ability to perform repetitive motion.

Schedule

• Monday–Thursday, 7:00 AM–5:30 PM (10-hour shifts, 4 days per week).
• Must be present at designated shift start-up times to ensure smooth production operation.
• Schedule may flex based on business needs that require nontraditional work hours.
• Ability to periodically work overtime as production needs require.