Supplier Quality Engineer

Title: Supplier Quality Engineer
Location : Latham, NY
Domain: Medical Device industry.

• • Implement Quality Engineering, Purchasing Controls, and Supplier Quality processes related to the development, procurement, and continuous improvement of manufacturing materials, components, software, sub-assemblies, contract manufactured finished devices, products, or services.
  • Evaluate suppliers' critical quality processes and ensure compliance with regulatory requirements and procedures.
  • Drive supplier improvement via SQIPs (Supplier Quality Improvement Plans) and lead the Supplier Change Notice process with support from Engineering, Quality Engineering, Assurance,
  • Qualify suppliers, assess their metrics, and audit their critical quality processes.
  • Ensure validations are completed where specified and control plans exist to ensure sustained quality and compliance of supplied raw materials and components.
  • Independently Produces and completes Supplier Quality Engineering related activities and documentation.
  • Completes Qualification of materials and components (including spare parts), development/ improvement of supplier processes for CtQ's, supplier process control plans; ensuring that the supplied part meets specifications, and the control limits/tolerances for CtQ parameters are met.
  • Qualifies and sustains sub- processes of suppliers, including performing process validations for critical supplier processes impacting part quality.
  • Ensures that the components/products at the supplier (including spare parts and services) are released according agreed specification and quality requirements (APQP / PPAP), and SQ audit results.
  • Executes SCAR management, effective and timely closure Regulatory, ME, R&D, Clinical, etc.
  • Experience in leading process improvement methodologies and organizational change management.
  • Proven record of accomplishment in developing suppliers and implementing lean methodologies at supplier end.
  • Develop and support regulatory compliance gaps at suppliers, including supplier quality system and process development activities.
  • Manage additions/deletions/changes to the status of suppliers on the Approved Supplier List, including supplier master file records
  • Ensure raw materials/components/products at supplier(s) are released from supplier(s) according to the agreed requirements.
  • Perform 3rd party product compatibility risk assessments in partnership with R&D and Market Procurement (Markets SQE).
  • Drive quality and compliance development and/or improvement at suppliers when needed.

• • Bachelor's degree in engineering or science discipline, or equivalent experience.
  • A minimum of 4 to 8 years of experience in establishing and maintaining regulated supplier management systems.
  • Engineer quality and ensure compliance for raw materials, components, finished products etc.
  • Certification with a recognized Accreditation body (i.e., RAB-QSA/IRCA) or successful completion of ASQ certification as a Certified Quality Engineer(CQE) and Certified Quality will be advantage.
  • Any Auditor (CQA) or Certified Biomedical Auditor or successful completion of a recognized Lead Auditor course will be added advantage.
  • Excellent communication skills in English (written and verbal).
  • Demonstrated experience in collaborative working environments, conflict resolution, and stakeholder influencing.
  • Ability to drive progress, take initiative, and achieve results.
  • Experience with technical drawings, specifications of parts.
  • Experience in Manufacturing process of welding, soldering, crimping, injection molding, plating, casting, and thermal forming
  • Experience with APQP (IQ,OQ,PQ) preferred.
  • Technical writing of protocols and reports.
  • Experience in ISO 9001, 13485 a plus.
  • Ability to travel to supplier sites within assigned region.
  • Looking for candidate who has extensive medical device domain industry experience.