Quality Assurance Inspector

Aptyx•Olympic Woods, NC

2d•Onsite

About The Position

The Quality Inspector I performs inspection and quality assurance activities in support of manufacturing and quality objectives to ensure products consistently meet customer, regulatory, and internal specifications. This role is responsible for inspecting incoming materials, in-process components, sub-assemblies, and finished medical devices while maintaining accurate documentation and supporting compliance with the Aptyx Quality System. The ideal candidate is detail-oriented, capable of working in a regulated cleanroom environment, and comfortable utilizing metrology equipment and inspection techniques within a fast-paced medical device manufacturing setting.

Requirements

High School Diploma or GED required
2–5 years of inspection or quality experience in a manufacturing environment
Basic computer proficiency required, including experience with data entry and electronic documentation systems
Ability to read, write, verbally communicate, and follow instructions in English
Ability to work extended periods under a microscope while maintaining inspection accuracy
Ability to work in a cleanroom environment for an entire shift, including wearing required cleanroom garments and PPE
Strong attention to detail and defect awareness
Ability to organize and prioritize work efficiently in a fast-paced environment
Ability to read and interpret engineering drawings, specifications, and work instructions
Experience using metrology and inspection equipment including: Calipers, Micrometers, Vision measurement systems, Inspection microscopes, Other precision measurement instruments
Strong documentation and data entry skills
Familiarity with Microsoft Office applications including Word and Excel, as well as Adobe PDF tools
Good hand-eye coordination and manual dexterity
Sound judgment and decision-making skills
Ability to maintain confidentiality in accordance with company policies
Ability to complete required training and retain knowledge necessary to effectively perform inspection responsibilities

Nice To Haves

Vocational or technical training preferred
medical device industry experience preferred
Experience working in a regulated environment preferred

Responsibilities

Follow the Aptyx Quality System, including all applicable SOPs, work instructions, and Training Matrix requirements
Inspect incoming materials to verify compliance with purchase order and specification requirements
Prepare and maintain inspection workstations, including organization, cleanliness, and material identification
Perform in-process, sub-assembly, and final product inspections to ensure compliance with customer and internal specifications
Conduct first article inspections (FAI) and complete associated inspection reports and documentation
Accurately complete inspection records, lot history records (LHRs), forms, and other quality documentation in accordance with applicable procedures
Perform line clearance audits and support production readiness activities
Identify, document, and communicate nonconformances or product defects to supervisors, engineers, production leadership, and/or Quality representatives
Support reject log activities and defect tracking processes
Maintain identification and traceability of materials, tools, and documentation throughout inspection activities
Perform lot release testing with guidance or support from higher-level inspectors, engineers, or quality personnel as needed
Notify supervision of equipment, tooling, or inspection instrument issues requiring maintenance or repair
Utilize metrology equipment including calipers, micrometers, microscopes, vision systems, and other inspection tools to obtain accurate inspection results
Support continuous compliance with cleanroom and controlled environment procedures
Maintain positive working relationships with peers, supervisors, and cross-functional teams
Work overtime as required to support production and business needs
Perform other duties as assigned