Hi, Please review the attached profiles-
*Sr QA, Selenium, Automation Test Engineer* *Name: Chandrasekhar Kamineni* Current Location: Baltimore, MD Relocation: Open Rate: Open /hr on C2C ** *__________________________________________________________* *Thanks & Regards* *Amy R.* *Professional IT Recruiter* ** *305-517-1786 / a...@csrinfotech.com <a...@csrinfotech.com>* *450 West Broad St, suite# 214 Falls church VA 22046* *E-Verify Certified Company* Confidentiality Notice: This e-mail message, including any attachments, is for the sole use of the intended recipient(s) and may contain confidential and/or privileged information. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail and destroy all copies of the original message. On Tue, Aug 7, 2018 at 3:17 AM, harish karnala <harirecruite...@gmail.com> wrote: > Hi, > > Hope you are doing well !! > > > > This is Harish From > USG.I have an Urgent Requirement for *Quality Engineer*. I hope your > resume fits for the below position. Kindly let me know your interest and > also required your updated resume. Please feel free to reach me any time. > > > > > > *Role *: * Quality Engineer(medical devices exp)* > > *Location* : Raynham MA > > > > > *JD* > > *Must have skills** > > *• A minimum of a Bachelor’s Degree, preferably in Engineering or related > technical field. Generally requires 3-5 years related experience. * > *• Experience working in both an FDA and European regulatory environment > is preferred. * > *• In-depth knowledge of product/process Risk Management (FDA and ISO > standards)* > *• Technical training and experience using Statistics, Lean and Six Sigma > Methodologies* > *• Good technical understanding of manufacturing equipment and processes > is required.* > > > > *Good to have skills** > > *- Good experience validations (IQ/OQ/PQ) * > > *Understanding of different types of metal/plastic cutting manufacturing > processes.* > > *Understanding of the NPI (New Product Introduction) process and Process > Validation expertise is preferred.* > > *The ability to perform "hands on" troubleshooting and problem solving is > preferred. * > > *The ability to think on the feet and providing sound judgment is highly > desired. * > > *A thorough understanding of GMP/ISO regulations and validation > regulations is preferred. * > > *Demonstrated project management and project leadership abilities are > preferred.* > > > > *Key responsibilities** > > *Business Improvements* > > *• Support quality improvement initiatives such as process and product > characterizations that lead to continuous / cost improvements.* > > *• Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean > Techniques and/or other improvement tools and programs.* > > *• Conduct benchmarking to develop more effective methods for improving > quality* > > *• Supports the development of quality engineering and quality compliance > with the right skill sets for new product introductions, and product life > cycle management. Compliance/Regulatory* > > *• Review/analyze whether current product and processes (including actions > or decisions conducted) are in compliance to standards such as the QSRs, > ISO 13485, etc.* > > *• Champions compliance to applicable Global Regulations and standards > (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) > including providing support during internal and external audits.* > > *• Conduct periodic line audits to assess for production controls such as > lot segregation. Review results of area audits to ensure that corrective > and preventive actions are adequate. Product Quality, Control & Disposition > and Performance Standards* > > *• Supports activities related to the Material Review Board.* > > *• Conduct investigation, bounding, documentation, review and approval of > non-conformances, CAPAs and customer complaints. Escalation of quality > issues as appropriate.* > > *• Accountability and ownership for material identification, material > segregation, classification of defect types including the successful > application of these techniques on a day-to-day basis in manufacturing. * > > *• Analyze/review effectiveness of preventive and corrective actions. > Review root cause investigation according to an established process.* > > *• Accountability and ownership of Quality metrics including maintenance > and reviewing of leading and lagging indicators of quality Product/Process > Qualification* > > *• Approve IQ, OQ, PQ, TMV or Software Validation Production/Process > Controls including Control Plans.* > > *• Partners with J&J Global Supply chain, Finished Goods and material > suppliers to ensure appropriate application of process validation, process > control, and risk management; and the investigation/correction of process > failures when needed.* > > *• Develop, interpret and implement appropriate process monitoring and > control methods consistent with the level of process/product risk. * > > *• Collect data and execute/conduct various analytical/statistical > analysis and interpretation as part of process improvements and day-to-day > support.* > > *• Develop, interpret and implement standard and non-standard sampling > plans* > > *• Assess effectiveness of measurement tools, destructive tests, > non-destructive tests, measurement system analysis. * > > *• Assess and interpret common versus special cause variation in > manufacturing processing and determine adequacy of current process limits. * > > *Risk Mitigation* > > *• Document, justify, review or analyze whether a proposed change to a > process will not enhance the risk level in some way beyond capability of > current controls or whether change will result in potential non-compliance > to a required standard such as the QSRs* > > > *• Assess the need for risk mitigation techniques given product > classification, potential defect types, defect frequency, severity, patient > risk, process capability, process controls, etc. Determine effectiveness of > these techniques on previously implemented improvements Strategic • Ensures > effective quality strategies are created for the validation of test > methods, process and design.* > > > > > > Harish Karnala > > United Software Group Inc.. > > 565 Metro Place South. Suite # 110 > <https://maps.google.com/?q=565+Metro+Place+South.+Suite+%23+110++Dublin,+OH+43017&entry=gmail&source=g> > > Dublin, OH 43017 > <https://maps.google.com/?q=565+Metro+Place+South.+Suite+%23+110++Dublin,+OH+43017&entry=gmail&source=g> > > Direct Number : +1 614-408 1549 > > Board Number : 614-495-9222 EXT. 622 > > Fax: 1-866-764-1148 > > > > karnal...@usgrpinc.com > > www.usgrpinc.com > > > > -- > You received this message because you are subscribed to the Google Groups > "CorptoCorp" group. > To unsubscribe from this group and stop receiving emails from it, send an > email to corptocorp+unsubscr...@googlegroups.com. > To post to this group, send email to corptocorp@googlegroups.com. > Visit this group at https://groups.google.com/group/corptocorp. > For more options, visit https://groups.google.com/d/optout. > -- You received this message because you are subscribed to the Google Groups "CorptoCorp" group. 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