QUALITY ENGINEER Must be strong with Minitab, statistical analysis and validations Minimum 2 years of experience working in the Medical Device Industry RESPONSIBILITIES * Perform drawing review for new and/or revised drawings. * Create/revise Inspection Plans as required. * Perform Tooling QA contract review. * Perform first time production order contract review. * Create qualification protocols for processes and equipment. * Review FA and Qualification results. Initiate corrective actions as necessary. * Prepare qualification reports for approval * Maintain Internal Audit system. * Identify opportunities for improvement and participate in improvement projects. * Monitor quality goals/metrics and report on status. * Other tasks as directed by management. REQUIRED EDUCATION OR EXPERIENCE Bachelor's Degree or equivalent work experience (Engineering degree preferred). REQUIRED SKILLS AND ABILITIES * Effective verbal and written communication skills. * Ability to multitask. * Proficient working knowledge of Microsoft Excel (including formulas and charting) and Minitab software. * Strong understanding of qualification requirements (IQ/OQ/PQ) for the medical device industry. * Ability to understand and analyze capability studies and determine required actions, as necessary. * Ability to read, understand and implement recognized sampling plans appropriate for Reny's manufacturing. * Blueprint reading and understanding of Geometric Dimensioning and Tolerancing. * Be accurate and attentive to detail. * Ability to assist and support others. About Aerotek: Aerotek, headquartered in Hanover, Md., is a leading provider of technical, professional and industrial staffing services. Established in 1983, Aerotek is an operating company of Allegis Group, the largest provider of staffing services in the U.S. Aerotek operates a network of more than 200 non-franchised offices throughout the U.S., Canada and Europe. For more information, visit aerotek.com. Aerotek is acting as an Employment Agency in relation to this vacancy. ()
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