Quality Engineer II

What You Will Be Doing

• Provide quality oversight for the Customer Health Management program, ensuring Voice of the Customer feedback is understood, metrics are established, and performance is monitored.
• Own quality oversight for assigned customers, including KPI monitoring, facilitation of root cause and corrective action activities, and management of “return-to-green” recovery plans.
• Create and manage corrective action reports using 8D methodology; lead implementation and effectiveness verification of corrective and preventive actions using tools such as 5-Why and Fishbone analysis.
• Analyze end-to-end order process trends to reduce Field Quality Reports (FQRs) and customer complaints through data-driven root cause analysis.
• Interface with internal and external customers, including Integration Centers, production facilities, and warehouse distribution teams, ensuring timely investigation and resolution of quality issues.
• Partner with Supplier Quality to drive improvements, including initiation and follow-up of Supplier Corrective Action Requests (SCARs).
• Support and improve ISO-aligned QMS compliance, including participation in internal, customer, and registrar audits.
• Drive progress toward strategic business and quality KPIs (e.g., FQR reduction, DPM improvement).
• Support onboarding of new customers, including risk management and development of project-specific processes and documentation to meet customer-specific requirements.

What We Are Looking For

• Bachelor’s degree (4-year) with 5–8 years of related experience.
• Experience working directly with customers and internal stakeholders to manage requirements and drive positive customer outcomes.
• Strong stakeholder management, communication, and collaboration skills across multidisciplinary and global teams.
• Demonstrated expertise in problem solving and root cause analysis, including development of effective corrective and preventive actions.
• Working knowledge of quality methodologies and tools, including CAPA/8D, Lean/Six Sigma, DMAIC, process mapping, control plans, and data analysis.
• Experience with risk evaluation and mitigation, including application of PFMEA methodology.
• Proficient knowledge of ISO 9001, including experience writing procedures and/or work instructions.

Preferred Qualifications

• Knowledge of ISO 13485 and medical regulations (advantage).
• Auditing experience and/or Lead Auditor certification.
• ASQ Quality Engineer (QE) certification and/or Lean/Six Sigma certification (preferred).