Sr Quality Systems Spec.

Medtronic

Colorado, USA
**
Fda title 21 cfr part 820
Iso13485:2016
Capa process
** Medtronic is seeking a Senior Quality Systems Specialist for their Colorado campus, working in a hybrid role that requires a deep understanding of the CAPA process and regulatory compliance. The ideal candidate will have at least four years of experience, strong problem-solving skills, and the ability to work independently while providing oversight for quality programs. **

Job Summary

  • At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all.
  • This position will lead (remotely) Site CAPA Board and CAPA Process improvement for current Medtronic Internal Customer located at USA.
  • Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values.

Matching Summary

Match Score: 75

** Medtronic is seeking a Senior Quality Systems Specialist for their Colorado campus, working in a hybrid role that requires a deep understanding of the CAPA process and regulatory compliance. The ideal candidate will have at least four years of experience, strong problem-solving skills, and the ability to work independently while providing oversight for quality programs. **

Skills & Requirements

Must-have

  • FDA Title 21 CFR Part 820
  • ISO13485:2016
  • CAPA process
  • root cause analysis
  • effectiveness
  • problem solving

Nice-to-have

  • emotional intelligence
  • capacity to influence
  • initiative and positive approach
  • continuous improvement thinking
  • story telling

Key Requirements

  • Minimum of 4 years of relevant experience
  • University Bachelor degree
  • US Visa: business (B1) or tourist (B2)
  • Fluent in English (C1-C2)

Work Rights

US Visa: business (B1) or tourist (B2)

Tailored Resume

Cover Letter