| Urgent openings for Medical Device & Regulations required in Irvine, CA- Day 1 onsite at Irvine, California, USA |
| Email: [email protected] |
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From: Priya Mishra, KKsoftwareassociates [email protected] Reply to: [email protected] Hello, Hope you are doing good. This is Priya from KK Software Associates LLC. We are the Preferred vendor for the clients. I found your resume suitable for one of the job opportunities we currently have. Please find the detailed job description and please do let me know if you are interested in this opening: Title: Medical Device & Regulations Location: Irvine, CA- Day 1 onsite Contract Experience (Years): 10 & above Role Description: Design Quality, Good manufacturing practices (GMP), CAPA/NC, Statistics, DFMEA, PFMEA, CAD, Root Cause Analysis, Manufacturing Process Competencies: EIS : Medical Device & Regulations Essential Skills: GMP (Good Manufacturing Practices) & ISO (International Organization for Standardization) 13485 and regulatory affairs Strong creative, analytical and problem-solving skills. Proficient at interpreting data and putting that data into a report Proficient at statistical analysis Root Cause Analysis Strong CAD Skills (Preferred Auto CAD and Solidworks) Strong Fixture design skills Experience in creating FMEAs & Writing reports Experience in PMS (Post Market Surveillance) Experience in PLM Tool (Windchill) Process experience, ability to observe and understand manufacturing processes Excellent Interpersonal / communication skills, Organizational / planning and Project management skills preferred Personal computer skills, Windows: word processing, presentation, e-mail, web browsers & spreadsheet software Ability to work efficiently, meet timelines, and communicate status (generate trackers, send emails, etc.) 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: Investigate field return products Perform root cause analysis on field returned products Manufacturing process optimization Work with stakeholders to reduce scrap Explore process improvement opportunities and support in implementation Support in Design Enhancement Work in a cross-functional team environment, working with engineering, manufacturing, marketing and suppliers Creation of ECOs to upload documentation changes to PLM system (Windchill) Know & follow policies & procedures related to work activities performedin area of responsibility Complete training in area of responsibility within allowed time-period and periodic retraining in areas Status: Open Keywords: Design Quality, Good manufacturing practices (GMP), CAPA/NC, Statistics, DFMEA, PFMEA, CAD, Root Cause Analysis, Manufacturing Process Thanks & Regards, Priya Mishra Lead US IT Recruiter 8751 Collin McKinney Pkwy, # 1302, McKinney, TX 75070 555 Metro Place North, Suite # 100, Dublin, OH 43017 Direct: (469) 325-3090 Email: Priya.m @kksoftwareassociates.com Web: www.kksoftwareassociates.com Keywords: information technology California North Carolina Ohio Texas Urgent openings for Medical Device & Regulations required in Irvine, CA- Day 1 onsite [email protected] |
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| 12:06 AM 07-Mar-25 |