Regional Quality & Compliance Leader

Linde Gas & Equipment; Tualatin (OR); On-site; USD 100,000 - 150,000; Full time

Job summary

Linde Gas & Equipment Inc. in Tualatin, OR is seeking a Region Quality Manager to oversee compliance across site networks, drive CAPA effectiveness, and prepare sites for FDA inspections.

You will lead investigations, train sites, and collaborate with Operations, Safety, Engineering, and Customer Service to improve quality performance and ensure adherence to FDA regulations (21 CFR 213) and CGMP principles.

Qualifications

• Bachelor's degree in a technical field such as Science, Engineering, or Quality, or equivalent experience.
• 3–5 years of experience in medical gases, pharmaceuticals, medical devices, or regulated manufacturing environments.
• Strong knowledge of FDA regulations, particularly 21 CFR 213 and current Good Manufacturing Practice principles.
• Experience conducting root cause investigations and managing corrective and preventive actions.
• Ability to travel regionally (40-60%) to support sites and investigations.

Responsibilities

• Evaluate site performance against quality policies, procedures, and standards to identify gaps and drive corrective actions.
• Lead regional compliance efforts ensuring adherence to medical gases, pharmaceuticals, medical devices, or regulated manufacturing environments.
• Conduct and oversee root cause investigations for medical gas complaints, ensuring timely closure, accurate documentation, and effective CAPA actions.
• Provide local training and coaching to sites on complaint handling, documentation practices, and quality fundamentals to strengthen compliance culture.
• Prepare sites for FDA and state inspections by conducting internal audits and offering guidance to maintain sustained inspection readiness.
• Collaborate cross-functionally with Operations, Safety, Engineering, and Customer Service to resolve quality issues and support continuous improvement initiatives.
• Analyze quality trends, complaint data, and CAPA effectiveness to deliver clear, actionable insights to regional and national leadership.

Skills

Root cause investigations

Training & coaching

Communication skills

Leadership

Quality assurance

Education

Bachelor's degree in technical field

Tools

FDA regulations knowledge (21 CFR 213)

Job description

Linde Gas & Equipment Inc. in Tualatin, OR is seeking a Region Quality Manager to oversee compliance across site networks, drive CAPA effectiveness, and prepare sites for FDA inspections.

You will lead investigations, train sites, and collaborate with Operations, Safety, Engineering, and Customer Service to improve quality performance and ensure adherence to FDA regulations (21 CFR 213) and CGMP principles.