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.
Duties and Responsibilities
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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
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High School Diploma or GED required
- Vocational or technical training preferred
Experience
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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
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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:
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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
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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
Acknowledgement
I have received a copy of this job description, have read and understood it, and will complete all assigned duties and responsibilities. I recognize that the company reserves the right to modify this job description and that I will be informed of any and all modifications prior to their effective date.
