Principal Quality Engineer

5 days ago


Westborough, United States Agile Search Inc. Full time

About the Role - This is a Principal Quality Engineer opportunity with a globally renowned medical technology company. This is a hybrid role and required to be in the office on a 2-3 days per week basis.


Key Responsibilities:

  • Serve as subject matter expert in quality engineering regarding advanced machining and single use devices.
  • Provide value to continuous improvement activities in product and process quality, validation, defect analysis, CAPA, and internal audits.
  • Provide internal expertise on sterilization matters, including release processes and oversight of sterilization supplier.
  • Ensure compliance with FDA, ISO, and MDR regulations, supporting internal and external audits.
  • Lead initiatives to improve quality systems, lean manufacturing, and Six Sigma activities.
  • Analyze quality data, prepare inspection procedures, and review engineering changes.
  • Supervise and mentor Quality Engineer.
  • Indirectly supervise and manage technical support staff.
  • Ensure environmental monitoring and product sterility requirements are met.


Qualifications

  • Bachelor’s degree in engineering and 8+ years of experience in medical device manufacturing and quality assurance.
  • Knowledge of sterilization, clean rooms, machining, and injection molding.
  • Proficiency in statistics, SPC, and quality engineering tools.
  • Strong communication, problem-solving, and organizational skills.
  • Experience with SAP and Minitab preferred.


Equal Opportunity: Agile Search is committed to considering exceptional individuals from all walks of life, regardless of identification of race, religion, gender, national origin, age, disability, marital status, or veteran status.



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