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HCL_ West Chester, PA Full time Position/Long Term Contract Client:-HCL Job Description . Lead quality engineer activities for risk management, as it relates to design and development, complaint investigations, and non-conforming materials. . Ensure high level of compliance to FDA QSR and ISO *13485* in all assigned areas . Work closely with internal departments (Operations, Advanced Operations and Research & Development) to provide risk assessments as required . Participate in project teams with internal departs to support product and/or process design and development activities . Perform literature review and analysis to support FDA submissions, utilizing medical knowledge and experience . Support the NC/*CAPA* process with risk assessments Required Necessary Tools:- · FDA · CAPA · MEDICAL DEVICE EXPERIENCE Minimum-5Yrs · ISO 13485 · MECHANICAL GRADUATE/ Bachelor's Degree in a life science/medical related field of study Qualifications/Work Experience . Minimum of three years working in medical or clinical setting, such as registered nurse, preclinical RN, clinical affairs . Demonstrate the applied knowledge of FDA and/or International medical device regulations . Demonstrate the ability to work effectively in cross functional teams . Demonstrate problem solving and troubleshooting skills . Demonstrate interpersonal and communication skills . Demonstrate ability to exhibit a positive, energetic approach to teamwork . Demonstrate ability to advocate product excellence and quality . Demonstrate ability to respond to urgent needs of the team, with proven track record of meeting deadlines . Proficient utilizing computers, including Microsoft suite, Outlook and Adobe Thanks & Regards Vinit Kumar Roy 408-722-9420 -- You received this message because you are subscribed to the Google Groups "IT provider" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. To post to this group, send email to [email protected]. Visit this group at http://groups.google.com/group/it-provider?hl=en. For more options, visit https://groups.google.com/groups/opt_out.
