Quality Engineer

1 week ago


Foxborough Foxboro, United States Oxenham Group Full time

Key Responsibilities:

Drive continuous improvement initiatives focused on enhancing process efficiency, product quality, and cost-effectiveness. Responsibilities include:

  • Handling non-conformance (NC) reports from start to finish, including initiating, analyzing, investigating, reviewing, and closing reports.
  • Collaborating with external suppliers to resolve NC issues efficiently.
  • Conducting audits of internal processes and supplier facilities in compliance with ISO-13485 and/or 21CFR820 standards.
  • Developing and implementing monitoring and control processes tailored to product risk levels.
  • Collecting and analyzing data using various statistical and analytical methods to support ongoing improvements and daily operations.
  • Leading investigations, documentation, and resolution of nonconformances, as well as managing Corrective and Preventive Actions (CAPAs) and customer complaints, escalating quality issues as necessary.
  • Taking ownership of material identification and segregation processes, applying defect classification techniques effectively within manufacturing.
  • Reviewing and analyzing preventive and corrective actions, and conducting root cause analysis following established procedures.

Note: This role may occasionally involve special projects beyond the listed responsibilities.


Preferred Qualifications:

  • Education and Experience: Bachelor’s degree with a minimum of years of experience
  • Demonstrated experience in a manufacturing or operational setting.
  • Strong understanding of product and process risk management, particularly within FDA and ISO regulatory frameworks.
  • Proven success in implementing risk mitigation strategies.
  • Certification in ISO-13485 internal auditing is highly preferred.


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