LOCATION: BEND, OR | FULL-TIME | ON-SITE

Join a team that’s committed to high standards, continuous improvement, and meaningful innovation. We’re seeking a Quality Specialist II to play a key role in driving quality and compliance across our organization. This position is ideal for someone experienced in regulated Quality Systems who thrives in a collaborative, fast-paced environment.
As a Quality Specialist II, you’ll support ongoing improvements across QA systems and ensure alignment with regulatory expectations. You’ll work cross-functionally with Quality, Laboratory, and Leadership teams to implement changes that improve quality, efficiency, productivity, and compliance.

• Lead the Corrective Action process for audit and inspection findings, including project planning, timeline management, and execution
• Oversee and support Change Management activities to ensure validated systems remain compliant
• Author and revise SOPs and quality documentation with a focus on process modernization and efficiency
• Support FDA inspection readiness by addressing high-risk compliance gaps
• Review equipment records and processes (PMs, calibrations, qualifications, logbooks)
• Perform QA reviews on non-conformance processes, CAPAs, and project reports
• Identify process inefficiencies and support efforts to reduce cost of poor quality
• Provide compliance oversight for improvement initiatives led by lab staff or other departments
• Stay current with applicable regulations (21 CFR Parts 11, 210, 211, 820; ISO 17025) and ensure internal adherence
• Support training initiatives and improve onboarding and quality system fundamentals
• Participate in vendor qualification activities and conduct on-site audits for high-risk vendors
• Act as a subject matter expert for EQMS processes, training users and supporting quality execution