Experience Requirements
Audit, monitor, evaluate and report on supplier quality related activities to assure fulfillment of safety and quality requirements and that a suitable quality system is maintained. Develop strong partnering relationships with Supply Chain, QA, Design, and Manufacturing groups. To serve as subject matter expert in the area of problem solving methodologies. Mentor others in those skills and procedures.
Qualification Requirements
Four year college degree with scientific/technical discipline.
Preferred Qualifications
Minimum 4 years experience working in medical device design, quality, quality engineering or manufacturing. Working knowledge of problem solving and root cause analysis. Working knowledge with suppliers. Knowledge of statistical techniques. Auditing experience. Knowledge and application of Quality System Standards and Regulations, e.g. ISO 13485, ISO 14971, 21 CFR Part 820. CQE desired. Basic Skills. Excellent verbal communication and writing skills. Experience with Visio, Access, Microsoft Word, Excel, PowerPoint, statistical applications. Training skills. Team facilitation skills.
Responsibilities
Manage, identify and review supplier corrective action plans and follow-up to assure completion and effectiveness in co-operation with the buyers. Coordinate component and product quality testing, if required. Support the evaluation and selection of suppliers through the application of quality tools and measurements. Review supplier change requests and develop and implement appropriate strategies to qualify and support the change. Analyze and identify trends from quality data and develop proactive measures with supplier in support of continuous improvement. Leadership and effective management of supplier related activities in support of business objectives. Participate in the supplier audit program. To serve as subject matter expert in the area of problem solving methodologies. Provide training to different levels of the organization on problem solving methodologies/root cause analysis to develop CAPA investigation skills. Provide other departmental support requested by immediate supervisor. Adhere to and ensure the compliance of Arrow's Code of Conduct, all Company policies, rules, procedures and housekeeping standards.
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