Staff Engineer-Supplier Quality in Gurugram at Stryker Corporation

Date Posted: 9/19/2019

Job Snapshot

Job Description

Basic Function
Staff Supplier Quality Engineers 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 Staff  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 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
Professional Requirements - Required
o bachelor’s degree in Engineering
o Minimum of 6-10 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: No

Travel Percentage: Up to 25%

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