Quality Control Inspector – Medical Devices (Sterile)

Regulatory Jobs; United States; On-site; USD 83,000 - 115,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Disability insurance

Paid parking/public transportation

Paid time off

Paid sick and safe time

Job summary

Siemens Healthineers is seeking a Quality Inspector to support incoming and in-process inspections of electromechanical assemblies and sterile consumables. You will generate NCMRs, maintain DHRs, and contribute to GDP-compliant records and continuous improvement efforts.

The role requires experience with ISO quality systems, GDP, CMM/vision-based inspection, and IPC 610 methods, with SAP and Excel proficiency. Overtime may be required.

Qualifications

• Experience in ISO 13485 or ISO 9001 quality systems in medical device manufacturing.
• Proficiency with GDP and sterile consumables documentation.
• Strong knowledge of CMM tactile/vision-based inspection.
• Certified Mechanical Inspector or equivalent preferred.
• Familiar with ANSI/ASTM/MIL/IEC test methods.
• Proficient with precision hand tools for inspection.
• Experience with optical comparators and vision systems (Micro-Vu).
• Ability to measure and verify geometric tolerances on electromechanical parts.
• Ability to interpret wiring diagrams and PCB schematics.
• Experience with PCB/PCBA inspection and IPC 610 methods.
• ERP/SAP experience strongly preferred.
• MS Office Excel for data entry and analysis.
• High attention to detail for traceability and sterility documentation.
• Ability to work overtime.

Responsibilities

• Perform incoming part inspections with emphasis on electromechanical components and sterile single use consumables.
• Conduct in-process inspections of assemblies to ensure compliance with design and sterile-use requirements.
• Inspect subassemblies and finished products, including single-use sterile consumables, for conformance to specifications.
• Generate and manage Nonconformance Reports (NCMRs) as required.
• Generate, review and maintain inspection records and reports in accordance with GDP.
• Review and maintain Part/Device History Records (DHRs), ensuring traceability of sterile consumables and electromechanical assemblies.
• Support continuous improvement, part investigations, and compliance initiatives across electromechanical and sterile consumable workflows
• Support Test Method Validation (TMV) and Inspection Method development activities.
• Perform other quality-related duties as assigned by management.

Skills

ISO 13485/9001

GDP & documentation

Attention to detail

Traceability

Wiring/PCB interpretation

Quality inspection

Tools

CMM tactile/vision

Vision systems (Micro-Vu)

Optical comparators

ERP SAP

IPC 610 methods

Excel

Job description

Siemens Healthineers is seeking a Quality Inspector to support incoming and in-process inspections of electromechanical assemblies and sterile consumables. You will generate NCMRs, maintain DHRs, and contribute to GDP-compliant records and continuous improvement efforts.

The role requires experience with ISO quality systems, GDP, CMM/vision-based inspection, and IPC 610 methods, with SAP and Excel proficiency. Overtime may be required.