*Hi Associate,* *This is Vicky, from IT-Scient. We have an urgent requirement for you. please find the Job Description below and interested please send me your most updated resume with following details on vi...@itscient.com <vi...@itscient.com>*
*Role : Testing Validation with Medical devices **manufacturing **domain* *Location : Pittsburgh, PA* *Duration : 6+ months* *JOB DESCRIPTION:-* POSITION SUMMARY: · Support R&D, Manufacturing Department to ensure compliance with quality system policies and procedures, FDA and international requirements, and ISO Standards for Medical Devices *DUTIES & RESPONSIBILITIES*: - *Experience in setting up Quality Management system and understand ISO 13485/14971/IEC 62304 / QSR requirements.* - *Support documentation for CAPA analysis / Closure, Change Management & related QA activities.* - *Develop Post-Market Surveillance reports* - *o Experience in acquiring the post market information to generate the Post-Market Surveillance report* - *Perform Risk Management activities as per ISO 14971 standard requirements – hands on experience (including, but not limited to, FMEA, Hazard Analysis etc.)* - *Research/Data gathering to support ongoing and new product in regards to: Hazards, Complaints review (internal and external (e.g. MAUDE)* Develop and execute Verification and validation protocols based IEC / AAMI and other regulatory standards as a member of product development teams, represents the QA function for Product Design throughout all stages of the Product Development Process. Develop QA plan for Design Function and Manufacturing Activities. Develop and initiate sampling procedures and statistical process control methods Create periodic quality reports, supporting quality, operations, and engineering functions Develop tools, test jigs and fixtures for verification / validation requirements Collaborate with manufacturing personnel in writing and reviewing process validation protocols and reports Summarize data using appropriate descriptive and inferential statistics. Collate, analyse and interpret statistical data for internal and external customers Drive Internal audits, supplier audits, customer audits; properly document activities in accordance with best engineering practices, company procedures, and regulatory requirements. ; Ensuring quality deliverables have been met and comply with regulatory and SOP requirements. Ensures compliance with design control procedures and identifies/implements best practices. Documentation support for 510(k) and TF for FDA and MDD requirements. *POSITION & QUALIFICATION REQUIREMENTS*: *Bachelor of engineering with 6 -8 years of experience in Medical Devices Industry ( Lead Role)* *Medical Devices manufacturing Industry experience along with the knowledge of FDA / ISO 13485 , IEC 62304 , ISO 14971 standard requirements* *Experience in Systems Design of Patient Monitoring devices / ultrasound scanners / infusion pumps/Radiology /Imaging systems etc.* *Certified Internal Auditor per ISO requirements; Experience with conventional inspection and measurement equipment* *Analytical ability in problem solving; Good communication skills, interpersonal skills, team work. A demonstrated commitment to company values.* ** *Thanks & Regards* *Vicky Kumar | Technical Recruiter* *IT–SCIENT LLC, Fremont, CA, USA* *ll IT-SCIENT - Talent Management Group ll* *ll Phone: 510 972 5217 ll Fax: 877.701.4872 <877.701.4872>* *EMAIL : vi...@itscient.com <vi...@itscient.com>* *Web: www.itscient.com <http://www.itscient.com/>* -- You received this message because you are subscribed to the Google Groups "REQSRESUMES" group. To unsubscribe from this group and stop receiving emails from it, send an email to reqsresumes+unsubscr...@googlegroups.com. To post to this group, send email to firstname.lastname@example.org. Visit this group at http://groups.google.com/group/reqsresumes. For more options, visit https://groups.google.com/d/optout.