Senior Engineer

Work Flexibility: HybridWhat you will do

• Support on Internal (Site) & External (Supplier) Engineering Change Management & participate in as required in CFT in conjunction with key stakeholders.
• Provide support to Internal/ External Customer groups on compliance issues related to assigned sites.
• Hands on experience of PPAP associated with New Product Launches and Management of Production cycles there after.
• 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. 
• 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 need:

Required-

• ​ B. Tech/ B.S. in engineering/ biomedical/ mechanical/ scientific or related field with 6+ years of working experience.

• Experience working in a regulated industry, preference given to Medical Device/ pharmaceutical experience.

• Experience with Computer Software Validation

• Strong written and oral communication skills. 

Preferred-

• Quality Processes/ Validation - Working knowledge of basic and advanced Quality tools such as; Six Sigma, SPC, FMEA, Control Plans, Root Cause Analysis, Poke Yoke, Kaizen, MSA & Equipment Qualification.

Travel Percentage: None

Experience Level

Senior Level