Regional Quality Lead: Medical Gas Compliance & CAPA

Linde plc; Tualatin (OR); Hybride; USD 110 000 - 160 000; Plein temps

Résumé du poste

Linde plc in Oregon is seeking a regional quality compliance professional to evaluate site performance against company quality policies, lead corrective actions, and drive CAPA effectiveness. You will conduct root cause investigations for medical gas complaints, provide training on documentation and complaint handling, and coordinate FDA/state inspections.

Travel regionally 40–60% to support sites and investigations, collaborating with Operations, Safety, Engineering and Customer Service to

Qualifications

• Bachelor’s degree in a technical discipline or equivalent experience.
• 3–5 years of experience in medical gases, pharmaceuticals, medical devices, or regulated manufacturing.
• Strong knowledge of FDA regulations, including 21 CFR 213 and GMP principles.
• Experience conducting root cause investigations and managing CAPAs effectively.
• Ability to travel regionally (40–60%).
• Excellent communication, training, and leadership capabilities.

Responsabilités

• Evaluate site performance against quality policies and drive corrective actions.
• Lead regional compliance efforts aligned with FDA expectations.
• Oversee root cause investigations and ensure timely closure.
• Provide local training on complaint handling and documentation practices.
• Prepare sites for FDA/state inspections via internal audits.
• Collaborate cross-functionally to resolve quality issues and support improvements.
• Analyze quality trends, complaint data, and CAPA effectiveness for leadership.

Connaissances

Bachelor's degree

Regulatory knowledge

Root cause analysis

Travel flexible

Communication skills

Formation

Bachelor's degree in a technical discipline

Description du poste

Linde plc in Oregon is seeking a regional quality compliance professional to evaluate site performance against company quality policies, lead corrective actions, and drive CAPA effectiveness. You will conduct root cause investigations for medical gas complaints, provide training on documentation and complaint handling, and coordinate FDA/state inspections.

Travel regionally 40–60% to support sites and investigations, collaborating with Operations, Safety, Engineering and Customer Service to