*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 "SAP Workflow" group. To unsubscribe from this group and stop receiving emails from it, send an email to sap-workflow+unsubscr...@googlegroups.com. To post to this group, send email to sap-workflow@googlegroups.com. Visit this group at http://groups.google.com/group/sap-workflow. For more options, visit https://groups.google.com/groups/opt_out.
