Staff Engineer, Quality Assurance

• Executing Change Managements & Manufacturing Changes associated with Machine moves, Process changes, validation updates.
• Executing Production part approval process for any change request.
• 3-5 Years of Experience of Handling team.
• SME for Validation (Validation PSPs, EQ, MSA execution)
• NC/ CAPA for internal Manufacturing issues (Clean, Pack, Label, Gage)
• Driving Internal Continuous Improvement projects at Site.
• Executing Gage Evaluation from QT's & focus on Gage/ fixture Updates & Development.
• Reviewing & providing inputs on Supplier Material Certificates.
• Ownership for site quality performance and measurement including KPI’s and participate in supplier performance reviews.
• Support quality issues with site & partner with Internal Customers; Lead effective supplier containment and corrections/corrective action.
• Provide support to Internal/ External Customer groups on compliance issues related to assigned sites.
• 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.
• Support on Internal (Site) & External (Supplier) Engineering Change Management & participate in as required in CFT in conjunction with key stakeholders.
• 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).

• B.Tech (Electronics/Electrical/Mechanical) with 10-13 years of experience in Quality / Engineering / Manufacturing environment, preferably from medical industry with ISO 13485 auditor certification is a must.
• Trained on Trackwise enterprise system, PLM would be an advantage.
• Intermediate level ability to use most MS tools (Word, Excel, PowerPoint, etc.)

• Supplier 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.

Stryker