Quality Systems Operations Lead – CAPA & Compliance

Siemens Healthineers AG; Pennsylvania; On-site; USD 134,000 - 184,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k)

Life insurance

Long-term disability

Paid parking/public transportation

Paid time off

Paid sick and safe time

Job summary

Siemens Healthineers is seeking a Quality Systems Operations Manager to lead QMS processes, CAPA, nonconformance, and audit readiness. You will drive continuous improvement with cross-functional collaboration across Quality, Manufacturing, Engineering, and Regulatory Affairs to ensure compliance with ISO standards and FDA QMSR.

The role emphasizes governance, metrics, and leadership across the Quality organization.

Qualifications

• Bachelor’s degree in Engineering, Quality Management, or related field.
• 5+ years in quality management or 3+ years with a Master’s degree.
• Experience with ISO 13485:2016 and FDA QMSR.
• Strong CAPA, nonconformance, and audit remediation experience.
• Leadership and cross-functional collaboration.
• Experience leading quality systems in a regulated environment.

Responsibilities

• Lead Quality Systems operations, governance, and continuous improvement of QMS processes.
• Oversee CAPA, nonconformance, audits, and regulatory inspection readiness.
• Establish quality performance metrics and reporting for governance forums.
• Partner with R&D, Manufacturing, Supply Chain, Regulatory Affairs and others to integrate quality requirements.
• Promote a culture of quality and compliance across the organization.

Skills

Quality management

CAPA

Root cause analysis

Leadership

Data analytics

Education

Bachelor’s degree in Engineering or Quality

Tools

SAP

ERP systems

eQMS

MES

Microsoft Office

Dashboards

Job description

Siemens Healthineers is seeking a Quality Systems Operations Manager to lead QMS processes, CAPA, nonconformance, and audit readiness. You will drive continuous improvement with cross-functional collaboration across Quality, Manufacturing, Engineering, and Regulatory Affairs to ensure compliance with ISO standards and FDA QMSR.

The role emphasizes governance, metrics, and leadership across the Quality organization.