Quality Engineer (CAPA Process)-Newark, DE

Siemens Healthineers

1d

About The Position

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. Where quality leadership meets real-world impact. When quality issues arise, how they are addressed makes a difference. In this role, you will serve as a key driver of effective corrective and preventive action, partnering across Manufacturing, Engineering, and Supply Chain to resolve issues at their root and prevent recurrence. You will help strengthen quality systems, support regulatory compliance, and ensure products are delivered with confidence and integrity in a regulated environment.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Supply Chain, or a related technical field
• 5+ years of experience in Quality, Manufacturing, Engineering, Supply Chain, or other regulated environments
• Hands-on experience leading CAPAs, nonconformance investigations, and cross-functional root cause analysis
• Strong knowledge of quality management systems and regulatory requirements (FDA 21 CFR Part 820, ISO 13485, GMP)
• Proven ability to collaborate and influence across operational teams
• Strong communication, analytical, and problem-solving skills

Nice To Haves

• Medical device experience preferred

Responsibilities

• Lead the end-to-end CAPA and nonconformance lifecycle, ensuring timely and compliant execution
• Partner closely with Manufacturing, Engineering, Supply Chain, and Supplier Quality teams to investigate issues and perform robust root cause analysis
• Drive corrective and preventive actions addressing process, equipment, supplier, and system-level root causes
• Serve as the central CAPA liaison between Quality and operational teams to ensure effective execution and closure
• Lead the Corrective Action Review Board (CARB), aligning priorities across quality and operations
• Monitor CAPA KPIs, trends, and effectiveness metrics to identify systemic risk and improvement opportunities
• Ensure CAPA and nonconformance records are complete, accurate, traceable, and audit-ready
• Support internal, supplier, and external audits as the CAPA subject matter expert
• Influence continuous improvement initiatives across manufacturing and supply chain operations

Benefits

• medical insurance
• dental insurance
• vision insurance
• 401(k) retirement plan
• life insurance
• long-term and short-term disability insurance
• paid parking/public transportation
• paid time off
• paid sick and safe time

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level