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 :
- Engineering, Technical, or Scientific discipline with years of related experience is required, preferably within a regulated environment (e.g. FDA regulated).
- Good Experience in IQ / OQ / PQ processes at Mfg sites
- Quality Engineering/Design or Process Excellence/Lean experience is preferred.
- Collaborate to complete Component Qualification, document evidence.
- Prepare Protocols, works requests & reports for Supplier Qualified components
- Collaborate with suppliers to collect evidence and/or develop Production Part Approval Process (PPAP)
- Knowledge of the QSR, Design Controls, and ISO quality requirements.
- Experience conducting Process / Design Failure Mode Effects and Analysis
- Understand and interpret all manufacturing audits, including ISO 13485 and other industry standards.
- Conduct supplier quality control audits on a regular basis to ensure vendors and their supplies remain in compliance with company and federal manufacturing and production standards.
- Experience in CAPA execution and Non-Conformance management
- Ability to work independently and partner with a cross-functional team (R&D, Regulatory, Manufacturing, and Purchasing)
- Mechanical product knowledge is preferred.
- Problem-solving techniques including 8D, root cause analysis, and cause and effect analysis
- Knowledge in PLMs & ERPs like WindChill, ADAPTIV, AGILE, JDE, SAP
