Senior Quality Engineer | Medical Device, CAPA & Risk

Stryker; Arlington (TN); On-site; USD 89,000 - 149,000; Full time

Job summary

Stryker in Arlington, TN seeks a Staff Quality Engineer to provide quality leadership across manufacturing and cross-functional teams. You will own CAPAs, NC investigations, MRB decisions, and supplier quality oversight while ensuring FDA, ISO 13485, and GMP compliance.

The role focuses on risk management, data-driven decisions, audits, and continuous quality improvements to support manufacturing transfers and new product launches.

Qualifications

• Bachelor’s degree in engineering or related technical discipline.
• Experience with CAPA, Risk Management, and root cause analysis in a regulated environment.
• Strong knowledge of ISO 13485, GMP, and FDA regulatory expectations.
• Experience supporting audits and quality systems in medical devices.

Responsibilities

• Provide quality leadership for manufacturing processes and product quality.
• Own investigations, NCs, CAPAs, and root cause analysis.
• Partner with Operations, Engineering, Supply Chain for quality oversight and compliance.
• Lead NC investigations, containment, CAPA closure, and supplier quality improvements.
• Disposition nonconforming products via MRB and support product holds or escapes.

Skills

CAPA

Risk management

Root cause analysis

Audits

Statistical methods

GMP/ISO13485

Communication

Education

Bachelor’s degree in engineering or related technical discipline

Job description

Stryker in Arlington, TN seeks a Staff Quality Engineer to provide quality leadership across manufacturing and cross-functional teams. You will own CAPAs, NC investigations, MRB decisions, and supplier quality oversight while ensuring FDA, ISO 13485, and GMP compliance.

The role focuses on risk management, data-driven decisions, audits, and continuous quality improvements to support manufacturing transfers and new product launches.