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Quality Assurance Associate

Linde plc.

Salt Lake City (UT)

On-site

USD 60,000 - 80,000

Full time

5 days ago
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Job summary

An established industry player is seeking a dedicated Quality Assurance Associate to ensure compliance with FDA regulations in the manufacturing of medical products. This role involves oversight of production processes, quality audits, and investigations into non-conformances. Join a forward-thinking company committed to enhancing productivity and sustainability in various markets, including healthcare and manufacturing. If you have a strong background in quality assurance and a passion for making a difference, this is an excellent opportunity for you.

Benefits

Competitive pay
Comprehensive benefits
401(k) Retirement Savings Plan
Paid time off
Employee Discount Programs
Career growth opportunities

Qualifications

  • Experience in reviewing manufacturing processes and quality oversight.
  • Knowledge of FDA regulations and quality improvement initiatives.

Responsibilities

  • Review manufacturing steps and report in-process errors.
  • Coordinate quality investigations and support audits.

Skills

FDA regulations knowledge
Quality assurance experience
Strong communication skills
Organizational skills
Basic HTML knowledge
Basic JavaScript knowledge

Education

Bachelor’s Degree in Science
Associate’s Degree in Engineering

Tools

Microsoft Office
Lotus Notes

Job description

Join to apply for the Quality Assurance Associate role at Linde Gas & Equipment

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 are performed in accordance with FDA regulations and LINDE’s SOPs. The role involves quality oversight, auditing production and incoming inspection activities, reviewing change requests, and investigating non-conformances and out-of-specification reports. The candidate should be able to work independently and provide consultative advice within their expertise.

What we offer you:
  • Competitive pay
  • Comprehensive benefits (medical, dental, vision, and more)
  • 401(k) Retirement Savings Plan
  • Paid time off (vacation, holidays, PTO)
  • Employee Discount Programs
  • Career growth opportunities
  • Hourly Rate: $27.00 - $29.00 (depending on experience)
What You Will Be Doing
  • Review manufacturing steps as per Batch Production Records
  • Report in-process errors and follow up on corrective actions
  • Coordinate quality investigations and ensure timely closure
  • Support product complaints, adverse events, and non-conformance investigations
  • Review Preventative Maintenance activities
  • Participate in Continuous Quality Improvement initiatives
  • Provide GMP and quality principles training as needed
  • Assist in review and approval of Change Controls
  • Support audits and update supplier and component specifications
  • Track and analyze deviations and complaints
  • Follow safety protocols and report incidents
  • Ensure proper product disposition and label review
  • Perform other duties as assigned
What Makes You Great
  • Bachelor’s or Associate’s Degree in Science, Engineering, or related field
  • Experience with medical product quality preferred
  • Knowledge of FDA regulations 21 CFR parts 210 and 211
  • Strong communication and organizational skills
  • Proficiency in Microsoft Office and Lotus Notes
  • Basic knowledge of HTML and JavaScript preferred
  • ISO 9001 or ISO 13485 experience preferred

Linde is a global leader in industrial gases and engineering, serving various markets including healthcare, electronics, and manufacturing. We are committed to making our world more productive and sustainable. For more information, visit www.lindeus.com.

We are an equal opportunity employer and encourage all qualified applicants to apply.

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