Staff EM & Supplier Quality Engineer

• Performs quality processes including change control, supplier non-conformance, quality agreements.  Participate in local site supplier/EM quality meetings to ensure communication and alignment of quality initiatives.  Lead supplier/EM quality evaluations.  Provide third party inspection support.
• Lead defect resolution, root cause investigation, and continuous improvement activities.  Collaborate across functions to confirm if non-conformances are supplier/EM related as applicable.
• Support internal and/or external cross-functional and cross sector project teams driving supplier/EM improvement and general initiatives through reducing variations in supply chain, institute control plans, and improving process capability.  Provide Quality Engineering support to suppliers/EMs including verification/validation activities.  Apply Quality Engineering tools such as Failure Mode & Effects Analysis (FMEA), Fault Three Analysis (FTA), Root Cause Analysis, Design of Experiment (DOE) etc., to the development of new products or processes related to raw materials, services, and finished products.
• Accountable, as applicable   for compliance in accordance with regulations such as and from, but not limited to, FDA Quality System Regulation, ISO 13485, EU MD Directive/Regulations,   FDA, 21 CFR 820; FDA Combo Product Regulation 21 CFR Parts 4 with 21 CFR 210/211, Japanese MHLW, Health Canada, Brazilian ANVISA,   Australian TGA for the company's products including medical devices and combination products.
• Maintain, support compliance of, and improve supplier/EM quality processes, including procedural and electronic systems. Support alignment with enterprise standards and executing gap assessments.  Provide regulatory guidance and interpretation to internal and external partners with regards to the following areas:  EM and Supplier Quality procedures, medical devices, and combination products.

Connect:

• Develop relationships with internal partners including Procurement, Material and Supplier Engineering, Quality Assurance, R&D, and suppliers/EMs.
• Review EM & Supplier Quality procedures and consider new ways to enhance effectiveness and share feedback with the process owners.

Shape:

• Consider how to apply new ideas you generated in EM & Supplier Quality processes.
• Brainstorm and test new ideas with others and remain open to and acknowledge different points of view.
• Find ways to challenge the status quo and how things have always been done; bring new ideas or innovations to bear on existing efforts

Lead:

• Develop your communication and influence skills to become a high impact presenter; seek feedback on your skills in this area.
• Identify & develop the skills necessary for future success.
• Get involved in non-profit activities aligned to the Credo.

External and Internal Interactions

• Main internal interactions are with Procurement, Material and Supplier Engineering, R&D Materials, Quality Assurance including Laboratory, Document Control
• Main external interactions are with Suppliers, EMs, and other J&J supplier quality groups.