Staff Supplier Quality Engineer

Job Title: Staff Supplier Quality Engineer GCF: 26 Location: Limerick For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and a broad culture that values different perspectives and life experiences That is why we in Limerick are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”! ABOUT THIS ROLE: The Staff Supplier Quality Engineer provides overall quality assurance leadership in the management and qualification of suppliers and/or external manufacturers (EMs). KEY RESPONSIBILITIES: Establishes and maintains quality assurance programs, procedures and controls, ensuring that performance metrics of both the supplier quality systems and suppliers are continually measured to drive improvement initiatives. This position aids in the identification and eliminate supply chain risks via internal and supplier partnerships. Leads/participates in supplier/EM engagements to assess technical competency and general compliance to requirements, i.e., material specifications, CTQ’s, process control plans, quality agreements, etc. Key areas of focus within supplier management are performance monitoring/reporting, compliance to J&J standards and streamline processes. Key areas of support provided to team members include risk management/communication, defect resolution, process capability/process improvement, and quality assurance general support. 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 inclusive of Laboratory, Document Control, R&D, and other J&J supplier quality groups. 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. Qualifications EDUCATION AND REQUIREMENTS: ESSENTIAL: Level 8 BA or BS degree is required. Minimum of 7 years of experience as a professional in a regulated industry, preferred Medical Device. OTHER SKILLS AND ATTRIBUTES: Demonstrates a basic understanding of the Medical Device Quality Systems, emphases on purchasing controls. Require working knowledge of Word, Power Point and Excel with competency in moderately complex functions for data analysis and trending. Experience in the Medical Device industry is preferred. Experience in the Pharmaceutical industry or Chemical, Packaging, or Plastics industry is an asset. FDA and ISO regulations knowledge. 21 CFR 820; 21 CFR 210/211; ISO 13485; ISO 9001; Canadian CMDCAS; Japanese PAL; Anvisa Australian TGA is preferred. Up to 30% travel, Full Time with weekday business hours. What type of mark will YOU make? By joining Johnson & Johnson you will find boundless opportunities to craft your path & amplify your impact inside & outside our walls. And with our commitment to be the world’s healthiest workforce you can strengthen your body as well and your mind. When you work with us you can touch over a Billion lives worldwide every day. And when you apply your talent to our collective purpose there’s no end to the lasting impact we can make together. And that changes everything. What’s in it for YOU? It’s vital to us that you feel you can bring your whole self to work; at J&J we provide an environment for you to fulfil your career aspirations as well as promoting your physical and mental wellbeing. You will receive a competitive wage and benefits package as well as benefits that can be tailored to what is valuable to you throughout different stages of your life. Examples of this include: online Digital GP, private healthcare, Retail Vouchers, Discounted & Subsidised Gym memberships and you can get to support community projects as part of our global Corporate Social Responsibility programme. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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INDHP Primary Location Ireland-Limerick-Limerick- Organization Johnson & Johnson Vision Care (Ireland) Limited (8182) Job Function Engineering Requisition ID 2206048670W