HCLTech
Supplier Quality Engineer ( Electrical Components )
HCLTech, Boston, MA, United States
About us : HCLTech is a global technology company, home to more than 223,400 people across 60 countries, delivering industry-leading capabilities centered around digital, engineering, cloud and AI, powered by a broad portfolio of technology services and products. We work with clients across all major verticals, providing industry solutions for Financial Services, Manufacturing, Life Sciences and Healthcare, Technology and Services, Telecom and Media, Retail and CPG, and Public Services. Consolidated revenues as of 12 months ending June 2023 totaled $12.8 billion. To learn how we can supercharge progress for you, visit hcltech.com. Website - http://www.hcltech.com
Job Details :
- Review and approve key quality records related to products in accordance with the Quality Agreement (QA) and Quality System Execution Plan (QSEP) as per Change Control process.
- Reviews high-risk CAPAs (i.e., Field Action, Critical Audit Observations, Major External Audit Observations, Near Misses and PRM).
- Partners with the SC to assess nonconformances resulting from the product release monitoring (PRM) process.
- Supports SC Quality and Manufacturing Engineering on the resolution of Quality issues impacting products and coordinates additional subject matter expert support needed.
- Supports SC on External Audit Readiness initiatives.
- Risk Assessment process (ISO 14971) and UFMEA, PFMEA, DFMEA and SFMEA process
- Mechanical, Electrical Drawings reviews.
- Knowledge in Electrical Components
- Knowledge in Medical Domain
- NCs (Non-Conformance)
- Process Verification Engineering (PVE).
- Design Transfer Inspection Requirement (DTIR) preparation based on Risk files assessment.
- Engineering support for the following activities :
- Test Method Validations.
- Master Validation Plans.
- Process Characterizations
- IQ/OQ/PQ.