Onsite Senior Quality Engineer - Medical Devices

Stryker; Virginia (MN); On-site; USD 89,000 - 149,000; Full time

Job summary

Stryker is seeking a Staff Quality Engineer in Arlington, TN to provide quality leadership across manufacturing operations and cross-functional teams. This role is responsible for risk management, CAPA ownership, supplier quality oversight, audit participation, and continuous improvement initiatives.

The successful candidate will serve as a quality subject matter expert, ensuring compliance with FDA, ISO 13485, GMP, and Stryker Quality System requirements while influencing business performance

Qualifications

• 4+ years in Quality Engineering or Regulatory in a regulated industry
• Strong knowledge of ISO 13485, GMP, and quality system requirements
• Experience with CAPA, Risk Management, Audits, Validation, and Statistical Methods
• Experience with Process Risk Assessments and Gauge R&R studies

Responsibilities

• Provide quality leadership and oversight for manufacturing processes and product quality.
• Own and drive investigations, nonconformances (NCs), CAPAs, and root cause analysis activities.
• Partner with Operations, Engineering, Supply Chain, and cross-functional teams to ensure product/process quality and regulatory compliance.
• Lead investigations and resolution of NCs, driving containment, root cause analysis, and CAPAs.

Skills

Quality engineering

CAPA

Risk Management

Root Cause Analysis

Audits

Validation

Statistical Methods

Process Capability

Education

Bachelor’s degree in Engineering or related technical discipline

Job description

Stryker is seeking a Staff Quality Engineer in Arlington, TN to provide quality leadership across manufacturing operations and cross-functional teams. This role is responsible for risk management, CAPA ownership, supplier quality oversight, audit participation, and continuous improvement initiatives.

The successful candidate will serve as a quality subject matter expert, ensuring compliance with FDA, ISO 13485, GMP, and Stryker Quality System requirements while influencing business performance