Supplier Quality Engineer

Job description

Work Flexibility: Hybrid What You will do: • Ensuring compliance to Supplier management activities identified by organization. • Experience of PPAP associated with New Product Launches and Management of Production cycles there after (Manufacturing Transfers). • Participate in cross- functional teams in the development of new products or changes related to current products in meeting customer requirements. • Applies sound, systematic problem-solving methodologies (5Why, DMAIC, 8D, C&E) in identifying, prioritizing, communicating, and resolving quality issues - NC & CAPA to facilitate root cause analysis and corrective actions of supplier quality issues. • Promote the use of continuous improvement methodologies such as Lean, Six Sigma, Poka- Yoke (Error Proofing), Measurement System Analysis (MSA), Statistical process control (SPC) and Process Failure Mode and Effects Analysis (pFMEA) • Evaluate Quality data to identify process improvement opportunities within the supply chain. • Coordinate Change Management & Control with Suppliers and implement changes at Supplier. • Review of process and equipment Validation including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Special Process Validations, and Test Method Validations. • Inspecting and testing materials, equipment, processes, and products to ensure quality specifications are met. • Prioritizing, reviewing, and delivering First Article Inspections FAIs for sustaining parts and development projects.   What you will need: Required Qualification: • B.Tech (Electronics/Electrical/Mechanical) with 2-5 years of experience in Quality / Engineering / Manufacturing environment. • Quality Processes/ Tools - Working knowledge of basic and advanced Quality tools such as; PPAP, Six Sigma, SPC, FMEA, Control Plans, Root Cause Analysis, Poke Yoke, Kaizen, Lean Manufacturing etc. • Executes/implements/ improve all supplier quality tools/ Processes. Trains supplier in these tools effectively. • Proficient in MS Office Suite (including Word, Excel, Power Point etc). • Strong interpersonal skills to work with cross-functional teams (engineering, R&D, manufacturing, regulatory affairs). Preferred Qualification: • Understanding of Medical Device Regulatory Compliance (ISO 13485, CFR 820, or comparable standard / regulation) and EU's Medical Device Directive. • Excellent communication and influencing skills, with the ability to manage multiple tasks and represent the Quality function across teams • Preferred ASQ Certified Quality Engineer (CQE). • Commodity Domain Knowledge – Strong Knowledge & understands technology, regulatory requirement related to product, system & services.      Travel Percentage: 10%