*Must have experience with CAPA and TMV(Test method Validation)* Hi
Hope you are doing well I am Smith, working as a recruiter with Infotree Service Inc. I am currently working on “*Verification/Validation Engineer*” position with *Medtronic* I will appreciate your response at the earliest, as the managers tend to move fast! *NOTE :** SEND RESUMES WITH THESE DETAILS , Profiles with all mandatory details would be processed with TOP Priority* *Name (First & Last)* *Contact No.* *Email ID * *Current Location* *Willing to Relocate if need* *Work Visa Status*, *Expiry Date* *Availability * How soon can you join?* *Reason for change* *Are you fine with drug and background check?* *Skype ID* *Last 4 Digit SSN No.* *DOB(Day, Month)* *Higher Education, Year of Completion * *Job Title* *Verification/Validation Engineer* *Project Location* *Northridge, CA 91325* *Duration* *12+ months /Contract* *Verification Engineer* *Job Description* Participate in the execution of new product development and sustaining products and administration of quality assurance programs, policies, processes, procedures and controls in compliance with the evolving and complex US and global requirements of the medical device industry. Plan, coordinate, and execute verification and validation activities to ensure the quality and reliability of Medtronic MiniMed products. Assure the timely, accurate and independent evaluation of product performance and compliance to product requirement, safety and regulatory requirements prior to manufacturing and market release. Provide support for released products, evaluate product field performance and reliability, recommend corrective actions, and actively participate in* CAPA*. Perform and document test method validation on verification testing of the products. Develop, execute and document product verification testing for any changes to sustaining products or changes to manufacturing processes to ensure compliance with established requirements and regulatory expectations. Ensure Design Quality Assurance-driven initiatives meet objectives in delivering highest quality products, with supporting tools and processes. *Position Responsibilities: * • Represent Quality in product development teams/projects. • Developed, execute verification test plans and protocols to ensure products meet requirement (safety, intended use, functionality, regulatory) to ensure provisions for quality are addressed & resolved prior to release. • Review all project / program hardware work products (e.g. plans, requirements, specifications, tests, test results, traceability, risk management documents, reports). • Coordinate with the development of essential design control deliverables including, but not limited to product performance analysis on similar products, essential requirements checklist, product specifications, risk analysis, failure mode and effects analysis, fault tree analysis, design verification/validation, design reviews, phase reviews, and product release authorization for distribution of product. • Work closely with business functions and project teams to develop appropriate verifications, validations, and test methods for both new design and changes to released product. • Review design inputs (specifications) and design outputs (reports, drawings, etc.) to assure that appropriate design requirements are specified and to evaluate/confirm quality requirements prior to successful design transfer. • Review & approve product verification and validation plans and reports. • Participate in CCB to review and approve engineering change requests. • Work with Manufacturing to direct, coordinate & monitor the production processes that are in compliance to FDA QSR, ISO 13485 and other applicable regulatory requirements (JPAL, Canada, etc.); and to ensure that safe and effective products are produced. • Provide validation support by applying manufacturing quality toolset including but not limited to: FTA, FMEA, DFEMEA, PFMEA, IQ, OQ, PQ, analysis, control plans, verification/validation plans, validation protocol development, Cpk, Cp, SPC, DOE, process data analysis, and DMAIC. • Participate in complaint investigations and failure analysis of returned products; document findings and provide reports and analysis to CAPA team. • Compile & institute quality metrics to trend, recommend and implement corrective action and appropriate follow-up when necessary. • Perform other duties as assigned. *Basic Qualifications: * • *Bachelor Degree* • 3 years related experience in Quality Assurance and/or Quality Engineering and/or R&D or Operations in a regulated environment (medical device). • 2 year experience in bio-medical or other regulated industry. • 2 year experience in plastic medical devices and molding processes. • Working knowledge of problem solving and statistical methods as applied to process and product quality. • Ability to write technical reports, business correspondence, technical procedures as well as administrative procedures. *Desired/Preferred Qualifications: * • MS Degree in Engineering (Electrical, Biomedical, Mechanical or equivalent). • *More than 5 years related* experience in Quality Assurance and/or Quality Engineering in a regulated environment. • Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 60601-1 and relevant international standards. • Experience with pFMEA, dFMEA, risk analysis and management. • Certified Lean or Six Sigma Black Belt. • Project Management experience. • Experience working with remote suppliers and facilities, both domestic and international. • ASQ certification in Quality or Reliability • An ability to interact with senior external personnel on significant technical matters often requiring coordination between organizations. • Self-Starter and accountable, with sharp focus on quality and customer experience. • Working knowledge of problem solving and statistical methods as applied to process and product quality. *Skills* • Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. • Ability to present proposals, data, and issues to Medtronic MiniMed personnel at all levels. • Ability to independently determine and develop approach to a wide range of issues and problems. Solutions must be thorough, practical, and consistent with organization objectives. • Ability to perform work with minimal direction and supervision. • Ability to represent the department in frequent inter-organizational and outside vendor contacts. • Ability to provide solutions to difficult technical issues associated with specific projects. • Ability to independently determine and develop technical solutions to a wide range of difficult problems. *Physical Job Requirements: * • The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. • While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. • Job entails the frequent manipulation of large pieces of equipment. • While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; talk or hear; and taste or smell. • Must be able to work within a Class 1000-Class 10000 clean room environment. • Must be able to examine subassemblies and work-in progress using a microscope operating at up to 100 x magnification. • Must be able to work in environments such as chemical lab with the appropriate protective equipment or in a machine shop where noise can be on the moderate side. • Employee must occasionally lift and/or move up to 50 pounds. • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. • On Call/After hours Support - May be required to support process and design validation efforts during weekends, 2nd shift as needed. Thanks & Regards Smith, Sr. Technical Recruiter Infotree Service Inc. 215 Ann Arbor Rd. Suite 304 Plymouth, MI 48170 734-446-7070 Fax- 734-345-4247 [email protected] -- You received this message because you are subscribed to the Google Groups "Oracle-Projects" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. To post to this group, send email to [email protected]. Visit this group at http://groups.google.com/group/oracle-projects. For more options, visit https://groups.google.com/d/optout.
