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Location

India | India

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Job description

Job Description

Work Flexibility: Hybrid

Basic Function:

This role is to implement a unified approach to Quality in Stryker with the intent to deliver high quality products and services in a manner that meets the high standards held by Stryker. 

Responsibilities :

This role will provide support to the Site Quality team to ensure compliance to technical, regulatory and Stryker requirements.

• Ownership for site quality performance and measurement including KPI’s and participate in supplier performance reviews.
• Support and execute on cost optimization activities e.g. part certification, Inspection reduction.
• Support Sites with root cause analysis on defective parts and critical quality issues e.g. Escape, Commercial Hold, Product Field Action.
• 3-5 Years experience of Handling team.
• Provide support to Internal/ External Customer groups on compliance issues related to assigned sites.
• 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. 
• 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) 
• Review development protocols including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Special Process Validations, and Test Method Validations. 

Professional Requirements :

• B.Tech (Electronics/Electrical/Mechanical) with 10-13 years of experience in Quality / Engineering / Manufacturing environment, preferably from medical industry.
• Intermediate level ability to use most MS tools (Word, Excel, PowerPoint, etc.) 

Technical Competencies  

• 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. 

Travel Percentage: None

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