Quality Engineer

3 weeks ago

Wayland, United States Whitridge Associates Full time

SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIES:


  • Supports regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
  • Key opinion leader for the oversight over manufacturing of assigned products, assuring compliance with DMR and quality system requirements and assuring complete and correct Device History Records are maintained.
  • Lead product and process improvement initiatives.
  • Leads and maintains the development, completion, and maintenance of risk analyses.
  • Supports the generation and completion of protocols and reports for product, process, and test method validations.
  • Support the development implementation, and maintenance of defect categories.
  • Collaborates with Manufacturing Engineers to review processes for new and existing products and supports the coordinate of process validations and capability studies.
  • Lead the development of various inspection techniques and procedures to ensure product integrity to design specifications.
  • Lead the disposition of non-conforming materials meet all necessary regulatory requirements, support the investigation process and assure adequacy of corrective actions to prevent re-occurrence.
  • Conducts complaint investigations and remediation recommendations as needed.
  • Lead CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
  • Conduct Supplier Audits and investigations as needed.
  • Provide leadership and oversight for Supplier Qualifications process.
  • Leads the product transfers process and the construction of any Device History Files.

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