Quality Inspector - Incoming Inspection

The Quality Inspector I - Incoming Inspection performs inspection and verification activities for incoming raw materials, components, packaging, and other products to ensure they meet Aptyx, purchase order, drawing, and customer requirements. This position supports the Quality team by accurately inspecting, documenting, and communicating inspection results while maintaining compliance with the Aptyx Quality System and applicable procedures.


The Quality Inspector I is responsible for identifying defects and nonconformances, maintaining accurate inspection records, and supporting the timely release of materials for manufacturing and production activities.


Duties & Responsibilities


Quality Inspection & Compliance

• Follow the Aptyx Quality System, including applicable SOPs, work instructions, and requirements identified within the Training Matrix.
• Inspect and verify incoming materials and components to ensure compliance with purchase orders, engineering drawings, specifications, and customer requirements.
• Inspect, verify, and approve the release of product, packaging, and shipping labels, ensuring information is accurate and legible.
• Perform first article inspections and complete the appropriate inspection reports and documentation.
• Perform line clearance audits as required.
• Audit samples of in-process components, sub-assemblies, and finished product to verify conformance with customer specifications.
• Maintain awareness of product quality requirements and the potential impact of defects on the customer and finished product.
• Maintain identification and traceability of materials, tools, procedures, and documentation throughout the inspection process.

Documentation & Quality Records

• Complete LHRs, inspection forms, NCRs, first article reports, and other required quality documentation accurately and in a timely manner.
• Maintain quality records in accordance with the Quality Manual and applicable procedures and work instructions.
• Provide documentation support to manufacturing and other functions as needed.
• Accurately enter inspection and quality data using applicable computer systems and software.
• Maintain accurate and organized inspection documentation.

Nonconformance & Communication

• Identify defects and nonconforming product through inspection activities and communicate findings appropriately.
• Document identified defects through the reject log and/or other required quality documentation.
• Communicate quality issues and unanticipated nonconformances to the appropriate Supervisor, Production Line Supervisor, Engineer, and/or Quality representative.
• Notify the appropriate Supervisor when inspection tools or equipment require repair or maintenance.
• Exercise sound judgment when evaluating inspection results and escalating quality concerns.

Work Environment & Teamwork

• Prepare, organize, and maintain the inspection workstation, including routine cleaning and organization.
• Maintain good working relationships with peers, co-workers, supervisors, and internal and external customers and suppliers.
• Complete assigned work efficiently and within established priorities and timelines.
• Work overtime as required.
• Perform other duties as assigned.

Education

• High School Diploma, vocational education, or equivalent experience.

Experience

• 2-5 years of inspection experience preferred.
• Medical device inspection experience preferred.
• Computer experience required.

Core Competencies


Quality & Attention to Detail

• Demonstrates a strong commitment to product quality and defect awareness.
• Consistently performs inspections accurately and thoroughly.
• Recognizes deviations from specifications and appropriately communicates concerns.

Technical & Inspection Skills

• Ability to read and interpret engineering drawings.
• Knowledge and demonstrated ability to use metrology and inspection equipment, including calipers, micrometers, vision measurement systems, inspection microscopes, and similar measurement instrumentation.
• Good hand-eye coordination and manual dexterity.
• Ability to work under a microscope for an entire shift.

Documentation & Computer Skills

• Skilled in completing procedures, reports, inspection records, and data entry accurately.
• Ability to work with Microsoft Office applications, including Word and Excel, and Adobe PDF programs.
• Ability to maintain accurate records in accordance with Quality System requirements.

Communication & Teamwork

• Ability to read, write, and verbally communicate effectively in English.
• Ability to follow written and verbal instructions.
• Communicates quality concerns clearly and appropriately to supervisors, engineers, and Quality personnel.
• Maintains positive working relationships with peers and other employees.

Organization & Judgment

• Ability to organize and coordinate work efficiently.
• Demonstrates good judgment when performing inspection activities and identifying quality concerns.
• Ability to complete assigned tasks within established requirements and priorities.
• Maintains confidentiality in accordance with Company policy.

Learning & Adaptability

• Ability to successfully complete required training and retain the knowledge necessary to perform Quality inspection activities effectively.
• Ability to learn and follow applicable procedures, work instructions, and Quality System requirements.

Cleanroom & Controlled Environment Requirements


The position may require work within a controlled production environment and cleanroom environment. Employees must be able to:

• Work in temperatures ranging from approximately 68°F to 80°F.
• Work in relative humidity conditions below 35%.
• Wear required cleanroom garments and PPE, including gowns, head/foot/hair coverings, and non-latex rubber gloves for an entire work shift.
• Perform inspection activities under a microscope for extended periods.

Physical Demands & Work Environment


The physical demands described below are representative of those that must be met by an employee to successfully perform the essential functions of the position. Reasonable accommodations may be made to enable

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.

Employee Signature


Date