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Senior Quality Engineer - Medical Device

Your tasks Champions site quality initiatives and participates in the development of site quality plan. Provides expertise in statistical analysis for Quality Engineering projects Leads and mentors cross-functional quality engineering project initiatives. Works with Quality Assurance Manager in providing back-up supervision of Quality Specialists and Quality Leads. Handles multiple projects and tasks, from product inception through product launch and maintenance.  Plays an active role in the processes to ensure products meet quality standards and are consistent with the site quality system. Supports plant activities in process validation, process capability improvement, and resolving customer issues by initiating corrective and preventive action, with an eye to increased capability and customer satisfaction that support the site Quality System. Helps establish manufacturing inspection, sampling and statistical process control methods, and procedures to assure quality of manufactured products. Assures compliance to in-house and external specifications and standards. Identifies and highlights quality issues by providing input to drive corrective actions to problems identified. Performs / leads root cause analysis to determine corrective action(s), as necessary. Interfaces with manufacturing in identifying and correcting quality issues for new and existing product lines. Assists with the investigation of root cause and determination of corrective and preventive actions relating to NCMRs, CARs, and QANs. Responsible for corrective action effectiveness verification after implementation of corrective actions. Works continuous improvement projects from beginning to end. Characterizes the problem, identifies key process inputs, determines optimal operating window, implements controls to maintain output at desired level, and quantifies the improvement in savings, avoidance, or value. Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results Internal and external contacts often pertain to company plans and objectives. Determines methods and procedures on new assignments, and may provide guidance to otherassociates. Our expectations Bachelor of Science degree in Engineering or related field 5+ years quality engineering experience which must be in the medical device industry with FDA experience Demonstrated competency in statistical process controls including control charts, data analysis, technical writing, continuous process improvement, including lean, six sigma, and validations. Passion for manufacturing with an on-floor presence to advance product quality standards Proficient with reading engineering drawings, written specifications, production documentation, using calibrated inspection equipment such as gauges, calipers, smart scope, multi-meters, manometers, pull test and otherinspection equipment. Certification in Quality Engineering, Biomedical Auditing, or equivalent Demonstrated knowledge in Quality System Regulations/Good Manufacturing Practices. Detail orientated, organizational skills and the ability to handle multiple projects. Strong team oriented professional with good interpersonal skills who is hands-on with a high energy approach to work Proficiency in the use of PC and programs, particularly Excel and Word to create procedures, work instructions, forms etc along with Minitab and Microsoft Project Ability to communicate ideas and information clearly, effectively, and frequently (oral and written). Flexibility to work different shifts as needed. Ability to travel as required (minimal). PreferredQualifications: Project managementexperience Experience and knowledge with injection molding manufacturing operations. Certified Quality Engineer (CQE), Certified Quality Auditor (CQA) and/or Regulatory Assurance Certification (RAC) Lean/Six Sigma certification.
Salary Range: NA
Minimum Qualification
5 - 7 years

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