QA/QC Technician

Air Clean Systems•Creedmoor, NC

6h•Onsite

About The Position

The QA/QC Technician oversees the calibration program, maintains equipment records, performs document control, and supports special projects to advance the Quality Management System. The role helps ensure activities and documents meet regulatory and compliance requirements. The position supports quality control of medical and non-medical devices, assists with complaint investigations, reviews service documentation, and performs inspections and audits as requested. This is a full-time, hourly, non-exempt position based at the Creedmoor, North Carolina office. General hours are Monday through Friday, 8:00 a.m. to 5:00 p.m., with an hour lunch break. Work is regularly performed in office and warehouse environments. No travel is required.

Requirements

Two-year degree in a technical or similar field.
Experience performing QC/QA activities in a quality system environment.
Familiarity with standard measurement equipment such as micrometers and calipers.
Excellent written and verbal communication skills.
Fluent in English, including speaking, reading, and writing.
Excellent organizational skills.
Proficiency with MS Office Suite, including Word, Excel, Project, Access, PowerPoint, and Visio.
Ability to exercise independent judgment within defined procedures and practices to determine appropriate action.
Ability to use logic to solve problems.

Nice To Haves

Bachelor’s degree in science, engineering, or a technical field from an accredited college or university, or equivalent work experience.
Working knowledge of FDA medical device regulations, guidance documents, and international standards including ISO 13485, ISO 14971, and ISO 17025.
Experience working with FDA-regulated medical devices, Class II minimum.
Experience developing SOPs, work instructions, Design History Files, Technical Files, and other supporting documents addressing domestic and international regulatory requirements.
Experience working with an ERP system.
Relevant combinations of education, training, and experience may be considered.

Responsibilities

Maintain calibration records and coordinate scheduled calibration with outside vendors.
Coordinate with Service, Production, and Lab teams to ensure calibrated equipment is identified, maintained, available, and organized.
Monitor preventive maintenance program performance; implement and update the program and adjust procedures and schedules as needed.
Assist with change order implementation and release by ensuring required training and documentation activities are completed.
Collect and maintain current-revision documentation needed to define regulatory requirements.
Provide controlled documentation to appropriate users and remove obsolete documents from distribution.
Perform document control activities to maintain the Quality Management System.
Perform clerical typing and generate documents as necessary.
Support quality control of medical and non-medical devices manufactured and sold by CS Medical.
Support complaint investigation and closure; conduct investigations and process complaints in accordance with company SOPs and regulatory requirements as requested.
Review and approve service-generated documentation from the field and depot.
Perform in-process quality control inspections and audits of materials, components, subassemblies, and finished medical-device assemblies as requested.
Provide guidance and training to company peers.
Complete assigned Quality Assurance special projects and contribute to ongoing Quality Management System improvement.
Perform other QC/QA-related duties as assigned by the supervisor.