Job Description

**Position Summary

**Responsible for performing incoming, first article (FAI), in-process, and final inspection activities on precision machined and assembled medical device components in compliance with ISO 13485:2016 and FDA 21 CFR 820 (QMSR). Ensures products meet engineering drawings, specifications, and regulatory requirements prior to release.This role has responsibility for inspection-based product acceptance decisions and support of nonconformance control activities.

**Reporting Relationship

**Reports to Head of Quality

Location: In-person

**Main Responsibilities

**

1. Product Inspection & VerificationPerform incoming, first article (FAI), in-process, and final inspection according to procedures, drawings, and specifications. Verify dimensional, visual, and functional conformance of machined and assembled components. Ensure only conforming product is released to the next process or shipment.

2. Product Release SupportSupport product disposition decisions based on inspection results and applicable procedures. Communicate inspection results clearly to production and engineering personnel. Ensure product status (Accepted / Rejected / On Hold) is properly identified and controlled.

3. Nonconforming Product ControlIdentify, document, and segregate nonconforming materials or products in accordance with procedures. Initiate Nonconformance Reports (NCR) and support Material Review Board (MRB) disposition activities. Support root cause investigation and Corrective and Preventive Action (CAPA) activities as required. Ensure nonconforming product is effectively controlled to prevent unintended use, assembly, or shipment.

4. Measurement Equipment & Gage ManagementVerify calibration status prior to use of inspection equipment. Operate and maintain precision inspection tools and gauges. Ensure proper identification, traceability, storage, and handling of all inspection equipment. Support calibration coordination activities with internal or external calibration providers. Perform routine care, cleaning, and functional verification of inspection equipment.

5. Documentation & Data IntegrityRecord inspection results accurately in compliance with Good Documentation Practices (GDP). Ensure traceability and completeness of all inspection records. Support batch record review and product release documentation as required.

6. Quality System SupportSupport First Article Inspection (FAI), Measurement System Analysis (MSA), and process validation activities as required. Maintain product identification and traceability throughout inspection activities. Support continuous improvement of inspection methods and quality processes.

7. Workplace Compliance & 5SMaintain cleanliness and organization of inspection area in compliance with 5S and contamination control requirements. Follow safety, GMP, and regulatory requirements at all times. Report abnormal conditions, deviations, or potential quality risks in a timely manner.

8. Other DutiesPerform other duties as assigned to support manufacturing, quality, and operational requirements.

**Minimum Qualifications

：

**

• Technical diploma or equivalent in Engineering, Manufacturing, or related field.

• 2+ years of inspection experience in machining, precision manufacturing, or regulated manufacturing environment (medical device preferred).

• Ability to read and interpret engineering drawings, including basic GD&T.

• Proficient in using precision measuring instruments, including but not limited to calipers, micrometers, height gauges, bore gauges, thread gauges, plug gauges, ring gauges, dial indicators, and surface roughness testers.

•  Ability to perform dimensional inspection using Coordinate Measuring Machines (CMM) (Hexagon preferred).

• Ability to measure and inspect machined components with accuracy and consistency.

• Familiarity with ISO 13485:2016 and FDA 21 CFR 820 (QMSR) preferred.

• Strong attention to detail and Good Documentation Practices (GDP).

• Ability to work independently and as part of a team in a fast-paced manufacturing environment.

• Proficient in basic computer applications including Microsoft Office (Word, Excel, Outlook).

• Ability to accurately enter inspection data, maintain electronic records, and work with basic manufacturing or quality systems such as ERP or similar systems (ERP/MES experience preferred).

**Work Schedule / Employment Conditions

**This position’s regular working hours are 7:00 AM to 3:30 PM. The role may require overtime, including extended weekday hours and occasional weekend work, based on production demands and business needs.

**Work Environment

**This position is an on-site position. It operates in both manufacturing and controlled inspection environments. The employee may be exposed to typical machining shop environments with background noise associated with production activities and fast-paced workflows.Personal Protective Equipment (PPE) is required in designated areas and must be used in accordance with safety policies. PPE may include safety shoes, safety glasses, gloves, masks, face shields, and protective clothing as required.The role requires high attention to detail, accuracy, and compliance with quality system and regulatory requirements.

**Physical Demands

**While performing the duties of this job, the employee is regularly required to stand, walk, use hands for precision measurement, and communicate effectively. The employee may occasionally lift up to 25 lbs.The position requires extended periods of visual inspection and computer-based documentation.Visual acuity is required for close-range inspection and evaluation of machined and assembled components.

**Transportation

**Reliable transportation to the workplace is required. The facility is located in an industrial area with limited public transportation access.

You should be proficient in:

• Quality Inspection Experience
• FDA Regulations
• Quality Control Experience
• Precision Measurement & Inspection
• Quality Control Data Analysis
• Blueprint Reading
• FDA 21 CFR 820 (QMSR)
• ISO 13485:2016

Machines & technologies you'll use:

• Coordinate Measuring Machine (CMM) (Hexagon)
• Measurement Gauges
• Calipers and Micrometers