Med Device QC Inspector - Electromechanical & Sterile

499x Siemens Healthineers Endovascular Robotics, Inc.

Elgin (IL)

On-site

USD 83,000 - 115,000

Full time

3 days ago
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Benefits offered by this job

Medical insurance
Dental insurance
Vision insurance
401(k) retirement plan
Life insurance
Disability insurance
Paid time off
Paid sick time

Job summary

Siemens Healthineers is seeking a Quality Control Inspector to verify electromechanical components and sterile consumables meet design and regulatory standards. The role emphasizes GDP documentation, NCMR handling, and traceability of DHRs across electromechanical assemblies.

The position requires experience with CMMs or vision systems, IPC 610 familiarity, and SAP-based ERP workflows. Applicants should be detail-oriented and able to work overtime in a regulated medical device setting.

Qualifications

  • Experience operating under ISO 13485 or ISO 9001 quality systems (medical device manufacturing preferred).
  • GDP experience and sterile consumables/documentation requirements.

Responsibilities

  • Perform incoming part inspections on electromechanical components and sterile consumables.
  • Conduct in-process inspections of assemblies to ensure design and sterile-use compliance.
  • Inspect subassemblies and finished products for conformance to specifications.
  • Generate and manage Nonconformance Reports (NCMRs).
  • Maintain inspection records and GDP-compliant documentation.
  • Review Part/Device History Records for traceability of sterile consumables and assemblies.
  • Support continuous improvement and investigations across electromechanical workflows.
  • Assist with Test Method Validation and inspection method development.

Skills

Incoming part inspections
In-process inspections
NCMRs generation
GDP documentation
DHR traceability
Gage R&R studies
PCB/PCBA inspection
ERP SAP experience
Excel data analysis
Sterile consumables knowledge

Tools

CMM
Optical comparators
Vision measurement systems
ERP systems (SAP)

Job description

Siemens Healthineers is seeking a Quality Control Inspector to verify electromechanical components and sterile consumables meet design and regulatory standards. The role emphasizes GDP documentation, NCMR handling, and traceability of DHRs across electromechanical assemblies.

The position requires experience with CMMs or vision systems, IPC 610 familiarity, and SAP-based ERP workflows. Applicants should be detail-oriented and able to work overtime in a regulated medical device setting.

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