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Supplier Quality Engineer

3 months ago

Danbury, United States BioTalent Full time

JOB RESPONSIBILITIES

  • Work closely with other departments such as engineering, production, and purchasing to address quality concerns and implement improvements. Represent the Americas during Innovation projects supporting the Product Creation Process while developing Initial Sample Inspection.
  • Review current suppliers and select/screen new suppliers as needed.
  • Quality Standards Implementation: Establish and implement quality standards and processes for purchased materials that suppliers shall follow.
  • Conduct scheduled audits of suppliers to ensure they adhere to quality standards and specifications.
  • Address and resolve quality issues or defects in collaboration with suppliers to prevent future occurrences.
  • Implement continuous improvement initiatives to enhance overall supplier quality and efficiency including specification and drawing reviews that support the specific Supplier Quality Plan.
  • Maintain accurate records and documents related to supplier quality, including inspection reports, corrective action plans, DFMEA/FMEA/PFMEA and Control Plans.
  • Identify potential risks in the supply chain and implement strategies to mitigate these risks.


REQUIREMENTS

  • Master’s degree in engineering in an industrial manufacturing or related field is preferred - Bachelors degree is required.
  • 5+ years in a manufacturing environment with focus on supporting product/process quality.
  • 5+ years in an ISO 13485 regulated environment.
  • 20% local travel required.