*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
*Role : Testing Validation with Medical devices **manufacturing **domain*
*Location : Pittsburgh, PA*
*Duration : 6+ months*
· 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
Create periodic quality reports, supporting quality, operations, and
Develop tools, test jigs and fixtures for verification / validation
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
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
*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
*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/>*
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