Supplier Quality Engineering

Our client is currently seeking a Supplier Quality Engineer in Mahwah, NJ. This is a 12+ month contract opportunity and will require basic knowledge of GMP, ISO 13485, and 21 CFR Part 820 standards. Please submit all qualified resumes to dglodek@judge.com. The Supplier Quality Engineer will have the following responsibilities: Working in partnership with the Global Supplier Network, you'll be involved in the ongoing support for the internal business units to address ongoing supplier quality issues, development of suppliers and ensuring that our external supply chain are capable of meeting expectations from a quality, service and cost perspective. You will serve as liaison between suppliers and the company to drive effective continuous improvement as a result of the supplier base. You will work with internal customers and suppliers in support of supplier quality issues; provide technical support for activities related to supplier quality system assessment and performance evaluation. You will collaborate with the strategic sourcing, auditing and development groups to understand the capabilities and competencies of suppliers to meet our requirements and continually meet and adapt to our product quality and regulatory requirements. This role will provide coaching and guidance to the SQE team to ensure compliance to technical, regulatory and company requirements. This person will also act as the Single Point of contact for communication of issues for the suppliers within their commodity alignment. Ownership for supplier quality performance and measurement including KPI's and participate in supplier performance reviews. Support quality issues with suppliers & partner with Internal Customers; Lead effective supplier containment and corrections/corrective actions Provide support to Internal/ External Customer groups on compliance issues related to assigned suppliers Support External Audits and Internal Audits as needed. Ensure Regulatory compliance in area of responsibility to GMP of all medical devices regulatory agencies (i.e. FDA, IMB, Notified bodies, etc) Participate in the supplier material related processes which include: Material Review Board to ensure Coordination of MRB activities with the business unit to ensure the timely assessment of potential non-conforming products. Maintain structured communication channels with strategic sourcing, identifying responsibility by commodity / supplier. Liaising with the Manufacturing and Quality groups, in assessing and addressing material quality issues with assigned suppliers. Maintenance of the Approved Supplier List (ASL) in conjunction with the Global Sourcing, Supplier Controls and Audit functions Support continuous improvement activities focusing on supplier quality Support the assessment of supplier changes Participate in supplier audit program - planning, execution and closure Participate in supplier reviews for assigned suppliers as required Participate in cross functional projects Support the developments and approval quality assurance agreements with suppliers. Qualifications & Requirements: Basic knowledge with GMP, ISO 13485, 21 CFR Part 820 standards Basic knowledge of FMEA, Validation Programs and SPC processes in a highly regulated environment desirable. Good communication skills. Willing to travel in support of business needs to different geographical locations. Good knowledge of continuous improvement methodologies Preferred industries are medical device, aviation, aerospace, automotive and defense Must enjoy working in team environment Must demonstrate good collaboration and communication skills. Highly motivated and able to build relationships internally and externally. Must demonstrate multitasking skills as this individual will be responsible for multiple tasks at the same time. The individual should enjoy working in a dynamic and results oriented team environment focusing on quality, compliance and customer satisfaction ID: 580534 Type: Contract Salary: Open

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