Quality Engineer - Capa Site Lead

Olympus Corporation of the Americas

Redmond, Washington, US
Base: $106,374.00 - $148,923.00 / year; bonus/equi...
On-site
Capa lifecycle expertise
Risk management principles
Root cause analysis tools
The position ensures consistent oversight and execution of Corrective and Preventive Action (CAPA) processes across the organization, supporting compliance with regulatory requirements and quality standards

Job Summary

  • The position ensures consistent oversight and execution of Corrective and Preventive Action (CAPA) processes across the organization, supporting compliance with regulatory requirements and quality standards.
  • The role drives cross-functional collaboration, facilitating structured problem-solving sessions, lessons learned, and continuous improvement initiatives across manufacturing, QA, QC, engineering, DA, R&D, PMS and supply chain functions.
  • We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.

Matching Summary

The position ensures consistent oversight and execution of Corrective and Preventive Action (CAPA) processes across the organization, supporting compliance with regulatory requirements and quality standards.

Salary

Base: $106,374.00 - $148,923.00 / year; Bonus/Equity: potential for annual bonus; Benefits: Comprehensive medical, dental, vision, 401(k) with match, PTO, paid parental leave

Skills & Requirements

Must-have

  • CAPA lifecycle expertise
  • Risk management principles
  • Root cause analysis tools
  • Cross-functional collaboration
  • eQMS proficiency (Agile, SAP, TrackWise)
  • Data analytics tools (Excel, Power BI, Minitab)

Nice-to-have

  • Mentoring and coaching skills
  • Influencing without direct authority
  • Data-driven decision-making culture
  • Continuous improvement mindset
  • Audit and inspection readiness

Key Requirements

  • 7-9 years of experience in Quality
  • 3-5 years leading CAPA or quality system
  • Experience as QA Manager, Quality Engineer, or Compliance Lead
  • Knowledge of FDA 21 CFR Parts 210, 211, 820 or ISO 9001 / ISO 13485
  • Bachelor of Science preferred

Work Rights

Not specified

Tailored Resume

Cover Letter