Quality Engineer

Work Flexibility: Hybrid

What you will do:

• Ensuring compliance to Supplier Control activities identified by organization.
• Hands on 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.
• Evaluating 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.

What you will need:

Required Qualification:

• B. Tech (Electronics/Electrical/Mechanical) with 2+ years of experience in Quality / Engineering / Manufacturing environment, preferably from medical industry. 
• Proficient in advanced power BI applications. 
• ISO 9001/13485 certification.

Preferred Qualification:

• 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. 
• Strong communication skills. Must demonstrate the ability to communicate up/down and across different levels of the organization. 
• Structurally collects facts to base his/her opinions on and ensures data integrity and traceability of data is flawless 

Travel Percentage: None