Region Quality Manager

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

• You will evaluate site performance against company quality policies, procedures, and standards to identify gaps and drive corrective actions
• Lead regional compliance efforts ensuring adherence to medical gas regulatory requirements including documentation, labeling, equipment maintenance, and operational controls aligned with FDA expectations
• You will be expected to conduct and oversee root cause investigations for medical gas complaints, ensuring timely closure, accurate documentation, and effective corrective and preventive actions
• Provide local training and coaching to sites on complaint handling, documentation practices, and quality fundamentals to strengthen compliance culture
• You have the ability to 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

Linde Gas & Equipment Inc.

Region Quality Manager

Tualatin, OR, United States | req32907

What you will enjoy doing*

• You will evaluate site performance against company 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
• You will be expected to conduct and oversee root cause investigations for medical gas complaints, ensuring timely closure, accurate documentation, and effective corrective and preventive actions
• Provide local training and coaching to sites on complaint handling, documentation practices, and quality fundamentals to strengthen compliance culture
• You have the ability to 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

What Makes You Great

• You hold a bachelor's degree in a technical discipline such as Science, Engineering, or Quality, or equivalent experience
• Three to five years of experience in medical gases, pharmaceuticals, medical devices, or regulated manufacturing environments
• Strong working knowledge of FDA regulations, particularly 21 CFR 213 and current Good Manufacturing Practice principles
• You have proven experience in conducting root cause investigations and managing corrective and preventive actions effectively
• Ability to travel regionally (40-60%) to support sites and investigations
• Excellent communication skills with demonstrated ability in training, coaching, and leadership

Why you will love working with us

Linde is a leading global industrial gases and engineering company with 2025 sales of $34 billion. We live our mission of making our world more productive every day by providing high-quality solutions, technologies and services which are making our customers more successful and helping to sustain, decarbonize and protect our planet.

Linde serves a variety of end markets such as chemicals & energy, food & beverage, electronics, healthcare, manufacturing, metals and mining. Linde's industrial gases and technologies are used in countless applications, enabling space exploration and launch technologies, delivering ultra-high-purity and specialty gases for semiconductor manufacturing, providing life-saving medical oxygen and enabling clean hydrogen production and carbon capture to reduce greenhouse gas emissions. Linde also delivers state-of-the-art gas processing solutions to support customer growth, efficiency improvements and emissions reductions.

What we offer you!

At Linde, the sky is not the limit. If you're looking to build a career where your work reaches beyond your job description and betters the people with whom you work, the communities we serve, and the world in which we all live, at Linde, your opportunities are limitless. Be Linde. Be Limitless.

Linde offers competitive compensation and an outstanding benefits package. Enjoy access to health, dental, disability, and life insurance, paid holidays and vacation, an employee discount program, and opportunities for educational and professional growth. Additional compensation may vary depending on the position and organizational level. Build your future with us while making an impact every day!

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability, protected veteran status, pregnancy, sexual orientation, gender identity or expression, or any other reason prohibited by applicable law.

Linde Gas & Equipment Inc. acts responsibly towards its shareholders, business partners, employees, society and the environment in every one of its business areas, regions and locations across the globe. The company is committed to technologies and products that unite the goals of customer value and sustainable development.

*The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Therefore employees assigned may be required to perform additional job tasks required by the manager.