| Supplier Quality Engineer at Elkton, MD Hybrid at Elkton, Virginia, USA |
| Email: [email protected] |
| From: Raj Khan, convextech.com [email protected] Reply to: [email protected] Hi, Hope you are doing good.!! Please let me know if you are interested in the below position.!! Position: Supplier Quality Engineer Location: Elkton, MD Hybrid Duration: 6+ Months Visa: Only USC/GC/EAD Interview: Video Job Description: Review of all new supplier add requests for impact on quality system and required controls Assess the suitability of suppliers to meet requirements through supplier evaluation, including supplier questionnaires, quality agreements and supplier site evaluations. Work closely with suppliers and R&D, Supply Chain and Quality Engineering groups to ensure potential suppliers for development projects meet requirements for qualification. Facilitating and performing component/material qualifications Assists in the development of DFEMA's (Design Failure Mode Effect Analysis) and PFMEA's (Process Failure Mode Effect Analysis) and control plans where required. Facilitating validations and component acceptance activities Identifying when gage r & r studies are needed Ongoing supplier management activities Building relationships with suppliers to ensure that purchased components meet specifications Drives continuous improvement in supplier performance through utilization tools such as Six Sigma DMAIC, FMEA, SPC, 8D Root Cause Analysis and Lean Manufacturing concepts. Optimize process capability on significant characteristics through effective application of statistical analysis techniques and training of Suppliers in problem-solving. Provide expert analysis, guidance and support to Suppliers in Process Improvement. Utilize analytical skill sets to implement root-cause analysis and provide recommendations for corrective action. Drives Supplier actions to verify component and process quality at the Supplier's location to reduce the need for incoming inspection activities. Manage the Supplier Corrective Action Request process. Requirements Requires a minimum of a 4 year degree in engineering, life sciences or a combination of prior work experience, education or combination thereof. 6 years medical device industry experience including minimum of five years of related experience in supplier quality engineering, prefer three years of on-site auditing experience Knowledge of national and international regulations applicable to medical devices including; Quality System Regulations, 21 CFR 820, 21CFR 803 and 804 (MDR regulations), Canadian Medical Device Regulations, ISO 14971, ISO 13485, and MDD 93/42/EEC Certification as a Quality Engineer (CQE) or Quality Auditor by the American Society for Quality (CQA) Trained in Six Sigma and Lean methodology; Greenbelt certification preferred Thorough working knowledge of Quality systems methods and practices (DOE, PFMEA, Control Plans, Lean Manufacturing concepts, DMAIC, Root Cause Analysis, CAPA, etc.) Experience working with suppliers on medical product quality issues Knowledge of medical product manufacturing and development Solid understanding of receiving inspection processes including statistical sampling, component measurement techniques, specifications and drawings Best Regards Md. Raj khan US IT Recruiter ConvexTech Inc. Email: [email protected] Linkedin linkedin.com/in/md-raj-khan-9b1498204 Keywords: rlang information technology green card Maryland |
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| Mon Mar 04 21:47:00 UTC 2024 |