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 :

Note : This is Day 1 onsite role.

• Engineering, Technical, or Scientific discipline with years of related experience in Medical Device industry
• Ensure that suppliers deliver quality parts, materials, and services.
• Qualify suppliers according to company standards.
• Review and approve the documents required to qualify through PPAP process (Control Plan, Flow Charts, Process Drawings, Capability studies, Design Failure Mode Effect Analysis (DFMEA) and Process Failure Mode Effect Analysis (PFMEA)
• Supplier risk segmentation.
• Supplier Quality Agreements.
• Supplier coordination in support of selection and qualification of new suppliers or changes to existing supplied products and processes.
• Support, review, and approval of Process Validation (IQ/OQ/PQ), MSA and Control Plan
• Route PPAP Checklist in Agile
• Leverage GMP (Good Manufacturing Practices). Navigates the complexities of various industry regulations to include FDA Quality System Regulation (QSR 21 CFR 820), ISO 13485, and ISO 14971.