HCL Technologies
Senior Technical Lead
HCL Technologies, Boston, Massachusetts, us, 02298
Job Description (Posting). Job Description:HCL to support Supplier Quality Engineering team for the below activities. Knowledge in Electrical Components Knowledge in Medical Domain NCs (Non-Conformance) Process Verification Engineering (PVE). Engineering support for the following activities. 1. IQOQPQ.2. Test Method Validations.3. Master Validation Plans.4. Process Characterizations Review and approve key quality records related to JJMD 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 JJMD products and coordinates additional subject matter expert support needed from JJMD. Supports SC on External Audit Readiness initiatives. Risk Assessment process (ISO 14971) and UFMEA, PFMEA, DFMEA and SFMEA process Mechanical, Electrical Drawings reviews Design Transfer Inspection Requirement (DTIR) preparation based on Risk files assessment (1.) To leverage design expertise to ensure that software and products exhibit user-friendliness, intuitiveness, and alignment with user expectations, contributing to the creation of seamless user experiences. (2.) To lead a team of designers, provide guidance, and ensuring the delivery of high-quality design solutions in alignment with the overall business goals. (3.) To present design concepts and play a crucial role in shaping the overall design vision and strategy. (4.) To stay abreast of industry trends, emerging technologies to drive innovation and excellence in design.