Quality Assurance Associate

Linde Gas & Equipment Inc
Quality Assurance Associate
Location: Cudahy, CA

The Quality Assurance Specialist will be responsible for reviewing and ensuring all steps in the manufacturing, testing, storage and distribution process for medical products performed in accordance with FDA's applicable regulations and LINDE's standard operating procedures. The Quality Assurance Associate will handle the quality oversight and auditing of production and incoming inspection activities, review of change requests, and investigation of non-conformances and out of specification reports. The Quality Assurance Associate will have the ability to work independently and to provide consultative advice within specific areas of expertise.

What we offer you!

• Competitive compensation
• 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: $27.04 - $39.65 hourly (commensurate with experience)

What you will be doing:

• Reviews all steps performed and ensures that the step in the manufacturing process has taken place as defined in the Batch Production Record.
• Reports findings of in-process errors and provides follow-up to ensure adequate completion of corrective actions.
• Performs and coordinates quality investigations with appropriate levels of corrective/preventive actions and closes in a timely manner.
• Supports product quality complaint investigations, assisting in data processing of Adverse Events and appropriate reporting for U.S. and Canada complaints. Supports the receipt/review of product complaint samples. Participates in the investigation and resolution of non-conformances of all types.
• Quality review of System Preventative Maintenance activities.
• Support initiatives in Continuous Quality Improvement.
• Provides training in GMP and quality principles to personnel in all departments when assigned. Assists in maintenance of training schedules and training records systems.
• Assists in the review and approval of Change Controls.
• Assists in internal and supplier audits and establishing/updating supplier and component specifications and testing as needed.
• Assists with tracking and trending of deviations and complaints.
• Follows all safety rules/regulations and immediately reports infractions and/or workplace injuries/accidents to proper personnel.
• Ensures for product disposition, e.g., approvals for release, distribution or rejection.
• Ensures labels are appropriately reviewed and approved for use and meet all internal and external requirements
• Other duties as assigned

What makes you great:

• Bachelor's/Associates Degree in a Science/ Engineering or related technical field
• Background in quality medical products preferred
• Knowledge in the FDA's regulations for medical products 21 CFR part 210 and 211
• Strong communication skills & organizational agility
• Solid organizational skills
• Strong knowledge of Microsoft Office Applications and Lotus Notes database skillsets
• Basic of HTML and JavaScript computer language preferred
• ISO 9001 or ISO 13485 and or regulatory experience

Why you will enjoy working with us

Linde is a leading global industrial gases and engineering company with 2023 sales of $33 billion.

Linde Gas & Equipment Inc. (LG&E) is part of the largest Welding, Industrial, Medical, and Specialty Gases companies in the U.S. We carry a comprehensive selection of industrial gases, such as oxygen, nitrogen, argon, and carbon dioxide, etc. LG&E has an extensive network of production plants, retail stores, distribution centers, and customer service locations with a focus on making our world more productive every day by providing high-quality solutions, technologies and services which are making our customers more successful by helping to sustain and protect our planet.

For more information about the company, please visit our website.

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.