drjobs Quality Engineer IV

Quality Engineer IV

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1 Vacancy
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Job Location drjobs

Santa Clara - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Job Summary :
  • We are seeking a highly experienced Quality Engineer IV to support quality systems compliance within the medical device industry.
  • This role focuses on managing quality systems integration regulatory support CAPAs and audits.
  • The position is 100 onsite and local candidates will be prioritized.
  • Candidates must be open to contract roles only.
Key Responsibilities :
  • Support and maintain quality systems to ensure regulatory compliance (ISOCFR Part 820 EU MDR)
  • Manage CAPAs nonconformances and prepare for audits
  • Lead projects related to quality systems integration and KPI dashboard management
  • Ensure labeling controls and documentation alignment with regulatory requirements
  • Support regulatory teams for compliance efforts (not involved in product submission
Requirements:
  • Bachelors degree in science or engineering.
  • 7 years of experience in the medical device industry.
  • Strong understanding of quality systems regulatory standards and audit processes.
  • Proven experience in CAPA management and quality system integration.
  • Experience supporting qualityrelated efforts during company transitions or acquisitions is a plus.

Employment Type

Full Time

Company Industry

About Company

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