• appraise supplier credentials, agreements and survey responses
• route new supplier requests for approvals
• work with suppliers to communicate requirements and establish process controls in alignment with engineering, manufacturing, quality and business objectives
• perform reviews with suppliers to determine manufacturability of components
• participate in the development of quality requirements for purchased component/assemblies
• review and develop risk mitigation controls for supplied parts
• assist suppliers with investigation and process improvement initiatives
• perform supplier audits (quality system, process and product audits)
• create supplier performance metrics and report on performance to suppliers and management.
• ensure alignment of supplier quality metrics with business objectives
• disposition nonconforming materials and initiate follow up activities to ensure proper corrective action and preclude recurrence of rejections.
• work with various engineering disciplines to resolve customer return issues related to supplier quality.
• work with incoming inspection to ensure proper part surveillance.
• review and approve first articles on custom fabricated components.
• minimum of three years' experience in quality engineering and/or supplier management, preferably in the medical device industry (note: supplier management experience in a highly controlled or regulated industry may be considered);
• knowledge of manufacturing processes, procedures and production equipment;
• auditing experience and training (asq-certified quality auditor and or lead auditor training for iso 13485
• familiarity with quality standards (iso 13485, iso 9001, fda qsr, etc.)
• demonstrated knowledge and experience with risk analysis, statistics and quality tools;
• background with cables, circuit boards, circuit board assemblies and/or molding processes are a plus;
• ability to travel (domestic & international) up to 25% of the time;
• strong problem solving ability;
• strong analytical skills;
• strong communication skills;
• excellent documentation skills;
• project management;
• flexibility and adaptability;
• ability to work with minimal guidance from direct supervisor;
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