Quality Assurance Associate

Praxair; Salt Lake City (UT); On-site; USD 50,000 - 80,000; Full time

Job summary

An established industry player is seeking a Quality Assurance Associate to ensure compliance with FDA regulations in the manufacturing of medical products. This role involves reviewing production processes, conducting quality audits, and providing consultative advice on quality assurance. The ideal candidate will possess strong communication and organizational skills, along with a relevant degree in science or engineering. Join a forward-thinking company committed to delivering high-quality solutions that enhance productivity and sustainability in various sectors, including healthcare and manufacturing. This is an exciting opportunity to contribute to impactful projects and grow your career in a dynamic environment.

Benefits

Competitive pay

Comprehensive benefit plan

401(k) Retirement Savings Plan

Paid time off

Employee Discount Programs

Career growth opportunities

Qualifications

• Bachelor’s degree in Science/Engineering or related field required.
• Knowledge of FDA regulations for medical products is essential.

Responsibilities

• Review and ensure compliance in manufacturing processes for medical products.
• Conduct quality investigations and support Continuous Quality Improvement initiatives.

Skills

Strong communication skills

Organizational agility

Solid organizational skills

Knowledge of FDA regulations (21 CFR part 210 and 211)

Basic knowledge of HTML

Basic knowledge of JavaScript

Education

Bachelor’s/Associates Degree in Science/Engineering

Tools

Microsoft Office Applications

Lotus Notes

Job description

Linde Gas & Equipment Inc.

Quality Assurance Associate

Location: Salt Lake City, UT

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 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

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 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 knowledge of HTML and JavaScript computer language preferred.
• ISO 9001 or ISO 13485 and/or regulatory experience.

Linde is a leading global industrial gases and engineering company with 2024 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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