Quality Control Inspector I

Job Summary

The QC Inspector serves as a key quality presence on the clean room production floor, providing inspection support, reviewing quality records, assisting with investigations, and driving timely resolution of quality issues. This position contributes directly to product quality, regulatory compliance, and continuous improvement initiatives.

Major Responsibilities

• Perform incoming, in-process, and finished product inspections using approved sampling plans and inspection methods.
• Review Device History Records (DHRs), batch records, sterilization documentation, and manufacturing records for completeness and compliance.
• Support release activities for finished products and ensure required quality documentation is complete and accurate.
• Assist with investigations related to nonconformances, deviations, complaints, supplier issues, and corrective actions.
• Support CAPA implementation, effectiveness verification, and follow-up activities.
• Assist with validation and verification activities including process validation, test method validation, and sterilization-related studies.
• Support supplier quality activities including receiving inspections, supplier issue tracking, and follow-up actions.
• Maintain quality metrics and prepare reports used for management review and quality performance monitoring.
• Assist during internal, customer, regulatory, and certification audits.
• Comply with Standard Operating Procedures (SOPs), Quality Systems, OSHA guidelines, and Medline's rules and regulations.

Minimum Job Requirements

Education: Typically requires High School Diploma or equivalent. No experience required.

Knowledge / Skills / Abilities

• Ability to read, write, speak and understand English.
• Attention to details.
• Vision abilities including close vision, distance vision, depth perception and ability to adjust focus.
• Basic math skills including addition, subtraction and fractional to decimal conversions.
• Working in hot and cold environments.
• Sitting, walking or standing for prolonged periods, with frequent twisting and bending.
• Working in PPE or company issued gowns for prolonged periods.
• Ability to lift up to 50 lbs.
• Ability to prioritize quickly in a fast paced manufacturing environment.
• Ability to process all relevant details, understanding and prioritizing their importance and drawing concise conclusions.
• Basic computer skills.
• Ability to apply basic knowledge of quality regulations such as GMP, GDP, ISO, or 21CFR 820, 210 - 211.

Preferred Job Requirements

• Experience in a medical device or other FDA-regulated manufacturing environment.
• Experience working in a cleanroom (ISO Class 7/8 or similar).
• Experience inspecting medical devices or components (incoming, in-process, or final).