| Quality Management, CAPA, TMV, Process validation, Design Controls, FMEA _ Minneapolis Downtown, MN at Minneapolis, Minnesota, USA |
| Email: [email protected] |
| Greetings, We have the below requirement with our client. Kindly go through the JD below and let me know your interest Role name: Engineer Minneapolis Downtown, MN Duration : Contract Role Description: Quality Management, CAPA, TMV, Process validation, Design Controls, FMEA Competencies: EIS : Medical Device & Regulations Experience (Years): 4-6 Essential Skills: Quality Engineer Knowledge of Medical procedure and corresponding Medical Equipment Good experience in CAPA execution, CAPA write-up Good experience in Test Method Validation (TMV) Good experience in Process Validation. Knowledge of Medical Equipment manufacturing processes Knowledge on Quality Management and its tools & techniques Knowledge about FDA, ISO 13485, ISO 14971 and compliance regulations Knowledge on NC, Audit processes Knowledge in Statistic, Risk Management and Design control Must possess good communication skills (verbal and written), familiar with project management methodology, problem solving, and presentation skills A minimum with 5+ years of related experience Quality Management in Medical Device Industry. Desirable Skills: Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, the duties and responsibilities for this position are: Working with other functional groups, including R&D and Operations in support of new product development, engineering projects, quality assurance activities, and lifecycle management. Utilizing Quality Engineering tools/processes in development and implementation of practices for the effective and efficient development. Non-Conformance Report (NCR) process for Sterilmed business unit. Develop and establish effective quality control and support associated risk management plans, AFMEA, DFMEA and PFMEA. Write, review and/or approve process and product validation protocols and reports, engineering change orders. Use statistical tools to analyse data, make acceptance decisions, and improve process capability, Design Controls, Design of Experiments Technical problem solving, failure analysis, and root cause determination. Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures. Strong communication skills. Candidates must be highly proficient in reading, writing, and speaking English language. A Minimum Bachelors Degree in Engineering, Science Best Regards, Jessica |Sr Techical Recruiter| Email: [email protected] Siri InfoSolutions Inc , 3 Ethel Rd, Suite # 302, Edison NJ 08817. Disclaimer: We respect your online privacy. If you would like to be removed from our mailing list please reply with "Remove" in the subject and we will comply immediately. We apologize for any inconvenience caused. Please let us know if you have more than one domain. The material in this e-mail is intended only for the use of the individual to whom it is addressed and may contain information that is confidential, privileged, and exempt from disclosure under applicable law. If you are not the intended recipient, be advised that the unauthorized use, disclosure, copying, distribution, or the taking of any action in reliance on this information is strictly prohibited. We are an equal opportunity employer with a diverse workforce. Note : Any resume submitted by Siriinfo is presented with the understanding that the candidate is being considered for your direct end-client (end-client is the company where the work will be performed). If there is any other company involved between the end-client and your company, please do not submit this resume without our written approval. If you submit the resume to another third party, Siriinfo reserves the right to work with the third party directly. -- Keywords: rlang information technology golang Minnesota New Jersey North Carolina Quality Management, CAPA, TMV, Process validation, Design Controls, FMEA _ Minneapolis Downtown, MN [email protected] |
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| Wed Jun 26 20:03:00 UTC 2024 |