Quality Assurance Specialist

Linde Gas & Equipment Inc.
Quality Assurance Specialist
Location: Fresno, CA or Bay Area, CA

The Quality Assurance Specialist will work extensively with Regional & Corporate Quality personnel to ensure Manufacturing and Warehousing locations meet or exceed FDA and corporate Quality requirements. This employee will ensure Quality incidents are properly reported, documented and investigated and manage Quality relationships with suppliers and regulatory authorities. The Quality Assurance Specialist will interface extensively with other LG&E and Linde Quality, R&D and Healthcare personnel.

This Quality Assurance Specialist will be responsible for the implementation of LG&E policies and procedures to meet and exceed government compliance requirements for medical gases and other quality assurance requirements. This position requires the ability to work independently and to provide consultative advice within specific area to assigned client base. Duties include performing a variety of medical gas quality assurance /audit and training in assigned area. The Field Quality Assurance Manager is accountable for continuously working to improve quality processes and reduce cost through operation excellence.

What we offer you!

• Competitive pay
• Comprehensive benefit plan (medical, dental, vision and more)
• 401(k) Retirement Savings Plan
• Paid time off (vacation, holidays, PTO)
• Employee Discount Programs
• Career growth opportunities
• Pay range: $76,500 - $112,200 yearly (commensurate with experience)

What you will be doing:

• * Provide FDA regulatory and Quality systems support to assigned locations within the Western desert mountain region
• * Assist assigned locations in training Managers, supervisors and personnel on Company and FDA GMP procedures
• * Audit/Assess assigned LG&E manufacturing and warehousing locations in addition, assess source material vendors for compliance to POIS and regulatory requirements for the manufacturing of drug gases and devices. Assessments to incorporate: GMP protocol, employee job observations, interviews, coaching and training. Communicate results of assessments through written reports and review meetings
• * Promote and participate in local Quality meetings within assigned locations
• * Act as compliance program advisor to region level Quality Assurance leaders
• * Assist in investigation and management of Customer Complaints and Internal non conformances
• * Other duties as assigned

What makes you great:

• * Bachelor's/Associates Degree in Science/ Engineering or equivalent required
• * 5 years Quality Assurance /management experience preferred
• * Strong communication skills & organizational agility
• * Solid organizational skills
• * Strong Spreadsheet/database skillsets
• * Working knowledge of ISO 9001
• * Packaged Gas Production Operations
• * Knowledge of Process and Analytical Methods
• * Knowledge of Quality Management System Principles
• * Regularly required to sit and talk and hear
• * Occasionally required to stand; walk; sit in front of a computer for extended periods
• * Occasionally lift and/or move up to 20 pounds
• * Up to 50% travel required

Linde is a leading global industrial gases and engineering company with 2023 sales of $33 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 and protect our planet. The company serves a variety of end markets including chemicals & refining, food & beverage, electronics, healthcare, manufacturing, and primary metals. Linde's industrial gases are used in countless applications, from life-saving oxygen for hospitals to high-purity & specialty gases for electronics manufacturing, hydrogen for clean fuels and much more. Linde also delivers state-of-the-art gas processing solutions to support customer expansion, efficiency improvements and emissions reductions. For more information about the company, please visit our website at www.lindeus.com.

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.

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