Description/Comment:
This Sr. Design Quality Assurance Engineer role is in support of a recent acquisition, where the QMS of an acquired company must be merged with the existing QMS. Experience in process flow mapping and documentation desired. Gather and analyze data to identify opportunities for quality improvements. Drive failure investigation to root cause when applicable using known engineering problem solving techniques. Conduct/Update risk analyses and track all findings, along with development of Risk Management portfolio, as required. Prior related experience in a regulated environment highly desired. Eagerness to assist internal and external customers. Manage projects in a timely manner. Participate in internal and external audits, as required. This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision.
Additional Job Details:
-Bachelors Degree required, with area of study in engineering required.
-Minimum of 5 years of engineering experience with a preference of at least 3 years of design related experience in a regulated environment.
-Agile development methodology experience highly desired
-Understanding and experience with product validation highly desired
-Understanding of Medical Device design controls highly desired
-The job requires attention to detail in making evaluative judgements based on the analysis of information. -Competent with Microsoft Office (Outlook, Excel, Word, etc.)
-Must possess excellent oral and written communication skills
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