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Quality Assurance and Regulatory Specialist

Littleton, CO
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Are you seeking a company that lives and breathes precision automation and values hands-on technical expertise in designing, building and servicing world class automated machinery for medical device manufacturers?

Are you looking to join a company where you can practically apply your education in a technically challenging high-precision, high-volume production environment? A place where junior and experienced engineers and technicians work collaboratively together in the same location to design and build highly customized, one-of-a-kind machines for some of the world’s best and most innovative companies?

Are you wanting to join a company that will continue to invest in your professional development throughout your career and offer you opportunities to work with other technical experts around the world?

At this automation company, they are a customer-focused organization that knows the importance of having teams comprised of collaborative, knowledgeable, innovative, and highly skilled employees. Their customers rely on their employees to bring technical innovation and creative thinking to their project every day to collaboratively overcome their greatest technical challenges.

They develop, produce and market automation and machining systems that enable extremely precise and productive manufacturing processes.

Working in the state of art 80,000 square foot production facility in Denver you’ll enjoy an innovative world-class facility and atmosphere. And with connections to their other offices around the world, the global footprint means you’ll be learning from the best technical experts around the world, not just in Denver or the United States.

Job Summary

The Quality Assurance and Regulatory Specialist is responsible for overseeing and maintaining the validated state of production processes and cleanrooms. Ensuring necessary documentation is complete and appropriately compliant with quality and client-driven regulatory requirements. Another key function of this role is to support company goals, values, and operating principles.

Essential Functions

  • Oversee production activities to ensure compliance to client Quality Agreements, quality system requirements (ISO 13485), and applicable regulatory requirements
  • Review and approve Batch Records for medical devices produced, propose lot release to client for approval
  • Review and approve environmental monitoring data and reports, schedule 3rd party testing as needed
  • Ensure nonconforming material is contained and documented as nonconforming
  • Perform root cause analysis using best practices, define action plans, and direct institution of corrective and/or preventive actions
  • Generate and update client Quality Agreements that outline all applicable quality and regulatory requirements for the product produced, ensuring regulatory boundaries are not exceeded
  • Handle Customer complaints

Technical Requirements

  • Thorough understanding of ISO 13485 and GMP standards
  • Familiarity with 21 CFR 820 and USP test methods
  • Maintaining a cleanroom
  • Establishing new processes and procedures

Location: Englewood, Colorado and does require on-site working conditions

Salary: 60-75K per year. Overtime paid and great benefits package

About Recruiting Firm, Riderflex

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Littleton, CO
80122 USA



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