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Quality Assurance Specialist

2 months ago

Chelmsford, Massachusetts, United States Teleflex Full time
Job Summary

The Quality Assurance Specialist will be responsible for ensuring the quality of all Teleflex products and processes, with a focus on manufacturing activities. This role will contribute to the development and implementation of quality management systems, and drive improvement in key areas such as CAPA and Nonconformance processes, Incoming Inspection, and Quality Improvement initiatives.

Key Responsibilities
  • Lead quality activities such as inspection methods, Nonconformance containment, correction, closure, and CAPAs; and drive improvement through analysis of trend data.
  • Support Incoming & In-Process Inspection teams, and participate in internal audit activities.
  • Review, change, and approve manufacturing procedures, test method validations, Quality Inspection plans, and process run sheets.
  • Perform change controls, and maintain compliance with Teleflex Global & local procedures and policies.
  • Support Engineering with new product development, quality planning, risk evaluation, and validation.
  • Maintain accurate records, and perform any additional QA tasks as assigned by QA Manager.
Requirements
  • Minimum 4-year degree in an engineering discipline, such as Mechanical, Biomedical, Plastics, or Industrial Engineering.
  • Minimum 2-3 years experience in quality and/or related manufacturing/engineering role, preferably in a manufacturing site.
  • Quality system management and deployment experience, problem-solving and quality improvement skills, and knowledge of ISO 13485, ISO 14971, and FDA QSR requirements.
  • Computer skills, including proficiency with Microsoft Word, Excel, and PowerPoint, and working knowledge of SAP and AGILE.