Medical Device QC Inspector – Sterile & PCB

Siemens Healthineers AG; Newton (MA); 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 AG seeks a Quality Control Inspector to ensure electromechanical components and sterile consumables meet regulatory standards. You will inspect mechanical, electrical (PCB/PCBA) and consumable parts, maintain GDP records, and support ISO 13485 quality system compliance.

Responsibilities include incoming and in-process inspections, NCMRs, DHR traceability, and continuous improvement initiatives across electromechanical workflows. Strong attention to detail is essential.

Qualifications

• Must have experience operating under ISO 13485 or ISO 9001 quality systems.
• Proficient in GDP and controlled documentation practices for sterile/medical devices.
• Experience with CMM and PCB/PCBA inspection is strongly preferred.
• SAP experience for tracking components and consumables is advantageous.
• High attention to detail and strict traceability in documentation.

Responsibilities

• Perform incoming part inspections on electromechanical and sterile components.
• Conduct in-process inspections of assemblies for design and sterility compliance.
• Inspect subassemblies and finished products for conformance to specs.
• Generate and manage Nonconformance Reports (NCMRs) as required.
• Maintain inspection records and GDP-compliant documentation.
• Review and maintain DHRs with traceability of sterile consumables and assemblies.
• Support continuous improvement and TMV/inspection-method development.
• Perform other quality-related duties as assigned by management.

Skills

ISO 13485 experience

GDP documentation

CMM inspection

PCB/PCBA inspection

SAP experience

Excel proficiency

Traceability

Attention to detail

Education

Certification: Certified Mechanical Inspector

Tools

Coordinate Measurement Machines (CMM)

Optical comparators

Vision measurement systems

Job description

Siemens Healthineers AG seeks a Quality Control Inspector to ensure electromechanical components and sterile consumables meet regulatory standards. You will inspect mechanical, electrical (PCB/PCBA) and consumable parts, maintain GDP records, and support ISO 13485 quality system compliance.

Responsibilities include incoming and in-process inspections, NCMRs, DHR traceability, and continuous improvement initiatives across electromechanical workflows. Strong attention to detail is essential.