Sr. Quality Engineer Loc:Memphis, TN

Repherrals (Memphis TN, USA) 9 days ago
Essentialjob Functions Ensure regulatory requirements (e.g. design control) and process/product goals (e.g. process capability) are met utilizing project/process planning and execution skills Work with multiple project schedules and manage competing priorities Identify specification needs/requirements & assist with the creation of specifications Support design transfer activities focused in development of gage design, inspection processes, GRR, capability studies and process validation Facilitate Design Review activities of new products and work closely with product design teams to ensure quality considerations during all stages of product development Provide guidance and help solve significant or chronic process or product problems. Discuss customer problems with Marketing and Sales as needed Generate, analyze, and present reports on quality related Key Performance Indicators (KPI) such as line yields, final release, supplier performance and customer experiences to internal product improvement teams Become proficient with SAP applications that track internal and external failures Support Quality Systems such as delivery holds, internal and external audits, CAPA and investigations Organize and track Material Review Board meetings and actions Track direct supplier quality and performance Manage and track non-conformance reports and CAPA review board meetings Analyze and trend complaint data. Perform root cause analysis and assign corrective actions. Qualification Requirements Bachelorâ??s degree (Masterâ??s preferred), in an Engineering discipline or equivalent technical background, with emphasis in Engineering or related fields preferred. Minimum 5 years (with Bachelorâ??s) or 3 years (with Masterâ??s) of experience with preferred experience working within the medical device industry and have the understanding of, and ability to interpret, regulations and guidelines governing medical devices including Knowledgeable of ISO 13485 and 21 CFR 820- Product Management experience is a plus Data analysis & critical thinking skills Ability to adapt & learn quickly Good written & verbal communication; responsiveness Ability to work well within a team and relate to all levels within the company Understanding and experience in applying quality assurance and control tools (statistical analysis, DOE, gauge R&R and SPC). Strong working knowledge of process development and validation methodologies (IQ,OQ,PQ). Experience interacting directly with suppliers, Manufacturing, and Manufacturing support organizations. Understanding and experience in applying quality engineering concepts such as process capability analysis, risk assessment, PFMEA and DFMEA. GD&T knowledge/experience (preferred) Electronics background (preferred)
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