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SQE (Supplier Quality Engineer)

hace 1 mes

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The Supplier Quality Engineer provides overall quality assurance leadership in the management of select contract manufacturing sites and raw material suppliers engaged in the production of medical products. He/She will utilize Quality Engineering tools for the effective and efficient development and maintenance of raw material and finished goods suppliers. Utilize Quality Engineering principles and problem-solving skills to develop and optimize supplier performance that are aligned with the overall Quality and Business vision. Ensure effective risk management to prevent unanticipated failure modes and ensure supply continuity.

PROJECT'S TRANSFER ACTIVITIES:
  • Plan and direct verification and validation activities as required at the 'receiving' site for transferring components and finished products.
  • Lead the transfer of parts, assemblies, documentation, and processes from the 'shipping' to 'receiving' sites.
  • Meet project goals, milestones, and target dates. Update and review project progress as required by the supervisor.
  • Interact with suppliers to obtain quotations and purchase components and equipment as needed to support transfer activities.
  • Lead and participate in technical phase reviews.
  • Support regulatory submissions, as needed.
  • Ensure that projects are developed and documented in accordance with the Quality System.

• Will conduct audits to good manufacturing practices, international organization for standardization and any other applicable standards.

• He/She will provide complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes.

• This individual will utilize multifaceted industry and process excellence standards on an expert level in daily quality operations, including good manufacturing practices (GMP), and international organization for standardization (ISO).

• The Supplier Quality Engineer will address and correct product and process complaints.

• He/She will report on contract manufacturer performance metrics and management reviews.

• This individual will oversee audits of all quality system categories to assess compliance to process excellence standards.

• The Supplier Quality Engineer will ensure comprehensive measurement systems to monitor the effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, presenting reports to management.

• He/She will handle complex technical issues for manufacturing processes that are to be transferred to facilities.

• This individual will provide Quality Engineering support to suppliers including audits/assessments, inspection technique support, verification/validation activities, CAPA and change management. FDA CFR Part 820 and ISO 13485 regulations/standards will be the focus.

• The Supplier Quality Engineer will partner with Engineering, Procurement and Raw Material and Finished Goods Suppliers to ensure the application of process validation, process control and process risk management.

• Implement and monitor process capability for continuous improvement.

• Develop supplier quality agreements.

• Develop systems to ensure the quality of purchased raw materials and finished goods.

• Ensure supplier performance.

Minimum Qualifications: Bachelor's Degree is required (Engineering, Life Science or related discipline is preferred).

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