Supplier Quality Engineer

Supplier Quality Engineer

Supplier Quality Engineer

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Accentuate Staffing is partnering with a local Medical Device company with their search for a Supplier Quality Engineer.  This is a Direct Hire role with a leading organization.

Responsibilities:

  • Ensure compliance to external regulations & standards and  policies on Purchasing Controls
  • Responsible and accountable for establishment, maintenance and oversight of Purchasing Controls processes and systems
  • Defend compliance to Purchasing Controls during internal and external audits of the facilities
  • Provide analysis, trending and oversight of Purchasing Controls CAPA as a result of internal or external audits
  • Accountable and responsible for communicating shared supplier issues and shared CAPA on Purchasing Controls
  • Assure that Quality systems and GMP of suppliers meet and regulatory requirements (scope includes all QMS relevant suppliers of specified components, assemblies, devices, contract manufacturers, special processes, software, services, logistics providers and consultants).
  • Responsible and accountable for maintaining the Approved Supplier List including the supplier master file for compliance with 21 CFR 820.50 and equivalent global QMS requirements (e.g., ISO 13485 sec 7.4).
  • Responsible for ensuring compliance (and validation) of Purchasing Controls applications in collaboration with IT and Procurement.
  • Execute the supplier quality audit program and follow up on supplier audit results including verification of the corrective actions.
  • Interact with various stakeholders to ensure effective quality problem resolution with suppliers
  • Accountable and responsible for establishment and reporting of supplier quality metrics.
  • Provide regulatory intelligence on Purchasing Controls to Q&R, Procurement, Operations, R&D, Finance (stakeholders).
  • Assure regular oversight over the establishment and execution of Quality Agreements with suppliers.
  • Support supplier QMS development including coordination/management of required resources.
  • Support supplier selection and capability assessments (including QMS, GMP & special process capability assessments).
  • Accountable and responsible for internal and external training on Purchasing Controls and related processes, including Medical device regulatory training (ISO 13485, cGMP), and Quality tools/ technical training.
  • Superior soft skills, good project management skills and ability to work with diverse cultures in a global team environment.

Requirements:

  • Possess a bachelor’s degree in Engineering or equivalent
  • Minimum of 5-7 years of Quality Assurance experience (regulated environment preferred)
  • Working knowledge of Quality System Regulation (QSR) and ISO 13485:2003, a plus
  • Experience in performing and maintaining Failure Modes Effects Analysis (FMEA)
  • Hands-on, demonstrable work experience with writing technical documentation.
  • Demonstrable work experience in test method validation techniques.
  • Certified Quality Engineer (CQE) preferred
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