Quality Systems Specialist

5 days ago


CO United States Medtronic Full time
Job Title: Senior Quality Systems Specialist

At Medtronic, we are committed to delivering high-quality products and services that improve the lives of our customers. As a Senior Quality Systems Specialist, you will play a critical role in ensuring that our products meet the highest standards of quality and safety.

Key Responsibilities:

  • Develop and maintain quality assurance programs to ensure compliance with regulatory requirements and industry standards.
  • Provide expertise and guidance on quality management systems, including CAPA management, audit program management, and Quality Management System improvements.
  • Support the development and implementation of quality policies and procedures.
  • Collaborate with cross-functional teams to identify and address quality issues.
  • Develop and maintain compliance policies supporting the Risk Management program.

Requirements:

  • Bachelor's Degree in Engineering, Science, or technical field with 5+ years of work experience in Engineering and/or Quality OR Master's Degree in Engineering, Science, or technical field with 3+ years of work experience in Engineering and/or Quality.
  • Expertise in CAPA compliance and investigation techniques.
  • Auditing experience to 21CFR820.30, 21CFR820.100, ISO13485, ISO 14971:2012, CMDR, the Medical Device Directive, and MDSAP.
  • Training in Risk Management, ISO 14971, hazard analysis, and Design FMEA.
  • Excellent written and verbal communication skills.
  • Excellent organizational skills.
  • Computer literacy, including proficiency with MS Office and experience with networks and applications.

Preferred Qualifications:

  • Master's degree in Engineering, Program Management, or Compliance.
  • Lead Auditor Certification to ISO 13485:2016.
  • ASQ CQE, CQA, CSQE, and/or CRE certification.
  • Familiarity with statistical software tools (Minitab, Stat Graphics, Statistica).
  • Familiarity with IEC 60601 and product-specific industry standards.

About Medtronic:

We are a global leader in medical technology, committed to improving the lives of our customers through innovative products and services. Our mission is to alleviate pain, restore health, and extend life. We are passionate about delivering high-quality products and services that meet the needs of our customers.

Why Join Medtronic:

We offer a competitive salary and flexible benefits package, as well as opportunities for professional growth and development. Our team is dedicated to delivering high-quality products and services, and we are committed to making a positive impact on the lives of our customers.



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