Job Id: 20200901027
Job Role: Senior Engineer Quality Assurance
Experience: 5 Years
Qualification: B.Tech (Electronics/Electrical/Mechanical)
Job Location: Gurugram
Salary: Not Mentioned
Vacancies: Not Mentioned
Job Description Stryker Recruitment 2020 Job Vacancies in Gurgaon Hiring for Electronics/Electrical/Mechanical Engineer in September 2020:
What you will do:
Ensuring compliance to Supplier Control 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.
Conduct Supplier Audits (Product, Process & System) and Facilitate root cause analysis and corrective actions of supplier quality issues.
Evaluate Quality data to identify process improvement opportunities within the supply chain.
Coordinate Change Management & Control with Suppliers and implement changes at Supplier.
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)
Review development protocols 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.
Collaborating with operations managers to develop and implement controls and improvements.
Ensuring that workflows, processes, and products comply with safety regulations.
Prioritizing, reviewing, and delivering First Article Inspections FAIs for sustaining parts and development projects.
What you need:
B.Tech (Electronics/Electrical/Mechanical) with Minimum of 5 years of experience in Quality / Engineering / Manufacturing environment.
Intermediate level ability to use most MS tools (Word, Excel, PowerPoint, etc.)
Quality Processes/ Tools – Working knowledge of basic and advanced Quality tools such as; Six Sigma, SPC, FMEA, Control Plans, Root Cause Analysis, Poke Yoke, Kaizen, Lean Manufacturing etc.
Executes/ Masters & implements/ improve all supplier quality tools/ Processes. Trains supplier in these tools effectively.
Commodity Domain Knowledge – Strong Knowledge & understands technology, regulatory requirement related to product, system & services. Determine supplier technical abilities based on these knowledges.
Knowledge of Simulation based/ Paperless Validation Tools:- Working knowledge of Paperless Validation Tools such as Val Genesis for verification of laser etching artworks.
Proficiency in prioritizing, reviewing, and performing First Article Inspections FAIs for sustaining parts and development projects
Knowledge of CAD software for creating/modifying artworks for development projects/sustaining parts.
Strong understanding of Medical Device Regulatory Compliance (EU MDR – Regulation (EU) 2017/745) and EU’s Medical Device Directive (MDD – 93/42/EEC)