Sr Quality Systems Spec.

MEDTRONIC

Hybrid
Fda title 21 cfr part 820
Iso13485:2016
Capa process
Medtronic is seeking a Senior Quality Systems Specialist with expertise in CAPA processes to support their Colorado campus in a hybrid work environment. The ideal candidate will have a strong background in FDA regulations, ISO standards, and quality assurance, along with excellent interpersonal skills for mentoring and collaboration

Job Summary

  • You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
  • 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: 85

Medtronic is seeking a Senior Quality Systems Specialist with expertise in CAPA processes to support their Colorado campus in a hybrid work environment. The ideal candidate will have a strong background in FDA regulations, ISO standards, and quality assurance, along with excellent interpersonal skills for mentoring and collaboration.

Skills & Requirements

Must-have

  • FDA Title 21 CFR Part 820
  • ISO13485:2016
  • CAPA process
  • root cause analysis
  • leading CAPA process
  • Microsoft Excel data analysis

Nice-to-have

  • customer service
  • emotional intelligence
  • capacity to influence
  • initiative and positive approach
  • proactive and innovative
  • willing to teach and mentor
  • continuous improvement thinking

Key Requirements

  • Minimum of 4 years of relevant experience about CAPA process
  • University Bachelor degree (engineering or equivalent)
  • US Visa: business (B1) or tourist (B2), probability to travel
  • Fluent in English (C1-C2): written and spoken

Work Rights

Not specified

Tailored Resume

Cover Letter