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Quality Assurance Inspector
Aptyx
- Charlotte, North Carolina, United States
- Charlotte, North Carolina, United States
Über
Duties And 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
Education
High School Diploma or GED required
Vocational or technical training preferred
Experience
2-5 years of inspection or quality experience in a manufacturing environment; medical device industry experience preferred
Experience working in a regulated environment preferred
Basic computer proficiency required, including experience with data entry and electronic documentation systems
Qualifications And Skills
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
Physical Demands and Work Environment This position primarily works within a controlled environment room (CER), cleanroom, manufacturing, packaging, and warehouse environment.
The Employee Must Be Able To
Sit, stand, and perform repetitive inspection activities for extended periods
Use hands, fingers, and vision for detailed inspection and measurement tasks
Work under a microscope for extended periods of time
Wear cleanroom garments including gowns, gloves, head coverings, and shoe covers throughout the shift
Lift and move materials up to 25 pounds occasionally
Communicate effectively verbally and in writing
Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Measurement of Performance
Completion of inspections and assigned quality activities accurately and within required timelines
Accuracy and completeness of inspection records, NCRs, first article reports, and related documentation
Proper and effective use of metrology and inspection equipment
Compliance with written procedures, quality requirements, and cleanroom practices
Timely identification and communication of product defects and nonconformances
Positive collaboration with peers, supervisors, production teams, and internal customers
Support of production quality objectives and continuous improvement initiatives
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Sprachkenntnisse
- English
Hinweis für Nutzer
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