*Hi Partner*
Warm Greetings for the Day ! This is RAJA from* GTSSMINDS Inc *!! Kindly Find the below JD and Send Suitable resumes to *r...@gtssminds.com* *Role : **Senior Quality Engineer (Medical Devices)* *Duration** **:** ** **6 Months contract * *Location** **:** ** **Philadelphia, PA* *Start date** **: ** **ASAP* *No of open positions** **: ** **03* Please have candidate fill below skill set matrix without fail. *Mandatory Skills* *No of years of experience* *Last used year* CAPA (End to End process ,from initial to end) Product quality management activities Complaint investigations Risk management FMEA, FTA etc. Medical Device industry experience *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* *Mandatory Skills:* *Some Manufacturing Design/development experience, Medical device industry, complaint investigations , CAPA process ,quality engineer activities for risk management, FDA regulations.* *Qualifications/Work Experience* . Minimum of three years working in medical or clinical setting, such as a 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 *Education:* Bachelor's Degree in a life science/medical related field of study. *Kindly Respond with Updated Resume, Contact Details, Visa Status and Expected Rate to* *r...@gtssminds.com* *Regards,* *R a j a* *Reach Me Via:* *Phone : (609) 890 0316 x808* *r...@gtssminds.com* *IM @ GTalk | Yahoo : rajarecruit* Google+ : https://plus.google.com/u/0/106223784641876125504 Facebook : http://www.facebook.com/profile.php?id=100000733180253 LinkedIn : http://in.linkedin.com/pub/raja-kumar-s-r/39/33b/147 Twitter : https://twitter.com/#!/RAJA051 -- You received this message because you are subscribed to the Google Groups "US_IT.Groups" group. To unsubscribe from this group and stop receiving emails from it, send an email to us_itgroups+unsubscr...@googlegroups.com. To post to this group, send email to us_itgroups@googlegroups.com. Visit this group at http://groups.google.com/group/us_itgroups. For more options, visit https://groups.google.com/groups/opt_out.
