Engineer

Job Title

Senior Supplier Quality Engineer

Relevant Experience

(in Yrs)

A minimum of Technical/Engineering Degree with 8+ years of related experience Medical Device Supplier Quality domain.

Technical/Functional Skills

• Working knowledge of regulatory compliance requirements (i.e. Quality System Regulations (QSRs), Medical Device Directive (MDD), ISO 9001, ISO 13485, ISO 14971 or other international standards) required

• Provides overall quality assurance leadership in the management of Direct, Indirect Suppliers and/or External Manufacturers engaged in the production of Johnson and Johnson products.

• Leads the deployment of the Supplier Quality Management (SQM) strategies and associated standards, policies, procedures, programs, systems, processes, and initiatives for suppliers of the CSS supply chain.

• Collaborate with Strategic Sourcing/Procurement, R&D, Engineering / Technical Operations, Quality, Operations, business partners/stakeholders, and external suppliers to implement solutions and improve suppliers' quality and overall service and performance.

• Supports the execution of plans/strategies, and impl ementation of systems, processes, and procedures to ensure robust supplier/purchasing controls with regards to the determination, selection, qualification, monitoring, and disengagement of suppliers.

• Excellence (PEx) tools in support of supplier-related changes, risk management,

• Product/process transfers, innovations, and continuous process enhancements to improve supplier reliability, minimize risks, and ensure sustainable sources of material supply capable of meeting or exceeding Quality, Compliance, and Business requirements

Experience Required

A minimum of 7 years of experience in Quality Engineering or Quality Assurance,

including data analysis, risk assessment and risk mitigation is required. Working experience in good manufacturing practice regulated environment is preferred.

(Medical device, pharmaceutical, etc.).

Roles & Responsibilities