Supplier Quality Engineer

Company : Katalyst Healthcares & Life Sciences

Job Summary:

• The Supplier Quality Engineer is responsible for implementing 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.
• The role focuses on ensuring supplier compliance with regulatory requirements, driving supplier quality improvements, and sustaining quality and compliance across the supply base.

Roles & Responsibilities:

• Implement Quality Engineering, Purchasing Controls, and Supplier Quality processes for manufacturing materials, components, software, sub-assemblies, finished devices, products, and services.
• Evaluate suppliers' critical quality processes and ensure compliance with regulatory requirements and procedures.
• Drive supplier improvement through Supplier Quality Improvement Plans (SQIPs).
• Lead the Supplier Change Notice process with support from Engineering, Quality Engineering, and Quality Assurance.
• Qualify suppliers, assess supplier metrics, and audit critical supplier quality processes.
• Ensure validations are completed where specified and control plans exist to sustain quality and compliance of supplied raw materials and components.
• Independently produce and complete Supplier Quality Engineering activities and documentation.
• Complete qualification of materials and components (including spare parts).
• Develop and improve supplier processes for Critical-to-Quality (CtQ) characteristics, including supplier process control plans.
• Ensure supplied parts meet specifications and CtQ control limits and tolerances.
• Qualify and sustain supplier sub-processes, including performing process validations for critical supplier processes impacting part quality.
• Ensure components, products, spare parts, and services are released according to agreed specifications, quality requirements, APQP/PPAP, and SQ audit results.
• Execute SCAR management and ensure effective and timely closure involving Regulatory, Manufacturing Engineering, R&D, Clinical, and other stakeholders.
• Lead process improvement methodologies and organizational change management initiatives.
• Develop suppliers and implement lean methodologies at supplier sites.
• Develop and support closure of regulatory compliance gaps at suppliers, including supplier quality system and process development activities.
• Manage additions, deletions, and changes to supplier status on the Approved Supplier List, including supplier master file records.
• Ensure raw materials, components, and products are released from suppliers according to agreed requirements.
• Perform third-party product compatibility risk assessments in partnership with R&D and Market Procurement (Markets SQE).
• Drive quality and compliance development and improvement at suppliers as needed.
• Support travel to supplier sites within the assigned region.

Education & Experience:

• Bachelor's degree in Engineering or Science discipline, or equivalent experience.
• Minimum of 4 to 8 years of experience establishing and maintaining regulated supplier management systems.
• Experience engineering quality and ensuring compliance for raw materials, components, and finished products.
• Certification with a recognized accreditation body (RAB-QSA/IRCA) or ASQ certification such as Certified Quality Engineer (CQE) or Certified Quality is an advantage.
• Certified Quality Auditor (CQA), Certified Biomedical Auditor, or completion of a recognized Lead Auditor course is an added advantage.
• Excellent written and verbal communication skills in English.
• Demonstrated experience in collaborative working environments, conflict resolution, and stakeholder influencing.
• Ability to drive progress, take initiative, and achieve results.
• Experience with technical drawings and part specifications.
• Experience in manufacturing processes including welding, soldering, crimping, injection molding, plating, casting, and thermal forming.
• Experience with APQP (IQ, OQ, PQ) preferred.
• Experience in technical writing of protocols and reports.
• Experience with ISO 9001 and ISO 13485 is a plus.

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