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Senior Supplier Quality Engineer en Gurugram a Stryker Corporation

Fecha de publicación: 6/13/2019

Resumen de la oferta

Descripción del empleo

Basic Function

Senior Supplier Quality Engineers (Sr. SQE) work with component suppliers, contract manufactures, and original equipment manufacturers, to ensure purchased components, sub-assemblies, and devices comply with all print specifications and applicable regulations.  The goal of SQE is to work with suppliers to create a best in class, high performing, and optimal supply base. Implement effective supplier quality and development programs aimed at improving supplier quality systems, change management, enhancing capabilities, and ensuring long-term quality from our suppliers.

Responsibilities

Responsibilities related to Supplier Performance Improvement:

o Create and implement supplier improvement plans

o Analyze supplier performance data and metrics (e.g. DPM, failure modes, trending, etc.)

o Provide suppliers with comparative data and metric performance

o Provide input to SDQE, Audit SQEs, and commodity team on supplier performance

o Obtain process performance data from suppliers (e.g. SPC, FPY, fallout, etc.)

o Present Periodic Supplier Performance Review for area of responsibility

Responsibilities related to Supplier Quality and Change Management:

o Visit suppliers to resolve issues

o Issue Supplier Corrective Action Requests and ensure suppliers implement robust corrective action which prevent recurrence (CAPA’s)

o Ensure timely and accurate documentation of audit-ready non-conformance records

o Execute Supplier Change Requests (SICR) related to manufacturing, process, or supplier requested changes

o Complete component qualification via PPAP and Change Board deliverables (e.g. process validation, FAI, 100% layout, capability studies, write protocol, execute test, write report, etc.)

o Develop, Establish and Implement DTS (Dock to Stock) process Improves quality and productivity Drives down inventory costs

Responsibilities related to Continuous Improvement:

o Identify areas of process and system improvement - Propose and implement changes

o Drive and execute CTG (Cost to Transformation) initiative in bringing continuous improvement and reducing the cost.

Supervisory Responsibilities

 No 

Professional Requirements - Required

o bachelor’s degree in Engineering

o Minimum of 6-8 years’ experience in Quality / Engineering / Manufacturing environment.

o Good knowledge with GMP, ISO 13485, 21 CFR Part 820 standards

o Working knowledge of FMEA, Validation Programs and SPC processes in a highly regulated environment

o Demonstrated working knowledge to influence positively the trend of the relevant supplier quality metrics.

o Strong analytical and problem-solving capabilities with the ability to draw insights from data quickly and to define executable actions

o Strong communication skills. Must demonstrate the ability to communicate up/down and across different levels of the organization.

o Willing to travel in support of business needs to different geographical locations.

Professional Requirements - Desirable

o Working experience in medical device industry is preferred.

o Good knowledge with GMP, ISO 13485, 21 CFR Part 820 standards

o Lead Quality Auditor Qualification either in AS 9100 or ISO13485, CFR820 or comparable industry standards and regulatory requirements

o ASQ CQE/CQM/PE certification

Work From Home: Yes

Travel Percentage: Up to 25%

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