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Quality Engineer

Cypress HCM
San Diego, CA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description
Quality Engineer Med Device
We are looking for a talented Quality Engineer for an exciting Medical Device Company. This is key position within the Quality Department to ensure compliance with regulations.
  • Develop project Quality Plans to enable new product implementation or changes to release product to meet regulatory requirements
  • Actively identify process improvements and drive implementation of changes
  • Review Product Development deliverables to ensure they are completed accurately and efficiently
  • Support post market product monitoring, and generate metrics for the teams
  • Develop and maintain QA procedures and forms
  • Develop and lead training for QA systems, create/ schedule/ conduct/ track yearly training and update the system.
  • Support the completion of risk assessment, as related to QA systems
  • Perform incoming inspection/ field investigations
  • Manage or support the response to audit findings and CAPAs
  • Review equipment qualifications (Installation, Operational, Performance)
  • Bachelor’s degree in engineering or science (Mechanical or Biomedical Engineer preferred)
  • Experience with medical device quality compliance requirements including ISO 13485, ISO 14971 and FDA 21 CFR Part 820
  • Knowledge of quality systems including Six Sigma, SPC, sampling plans, process mapping, inspection and testing
  • Excellent communication skills to effectively provide written and verbal communication to supporting teams
  • Ability to effectively write reports, work instructions, and procedures
  • Proven ability to interpret quality and regulatory
  • Leadership and flexibility to work with the business to address quality risks and improvements
  • Internal audit certification preferred
Salary Expectations:
  • $100-135K

Cypress HCM


San Diego, CA



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