Monitor defect trends, inspection results, and quality performance; escalate issues promptly and ensure containment actions are implemented.
Ensure strong day‑to‑day control of QC stations, inspection methods, and acceptance criteria.
To manage the in-process Quality control and conduct audits as planned; issue Internal CARs, drive CAPA implementation till closure within the defined timeline.
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Candidates should possess hands-on expertise in Functional Testing, including regression, integration, and system-level verification.
Candidates should have strong analytical and problem-solving skills, with attention to detail and thorough documentation practices.
Candidates should have familiarity with test management tools and issue-tracking systems, and the ability to collaborate effectively in cross-functional teams.
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Life Unlimited. At Smith+Nephew, we craft and manufacture technology that takes the limits off living.
The Quality Engineer is responsible for supporting engineering projects and ensuring the quality, reliability, and continuous improvement of products and manufacturing processes. The role applies quality engineering principles, risk management, and problem-solving techniques throughout the product lifecycle to maintain compliance and drive operational excellence.
The position also reviews and approves Device History Records (DHR) for product shipment, investigates non-conformances and customer complaints, and supports root cause analysis and corrective actions. Working closely with cross-functional teams, the engineer helps improve process capability and product quality while supporting day-to-day manufacturing operations.
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Coordinate and consolidate build performance report within factory NPI team and align quality statement to QPM (Quality Program Manager) & Program Manager.
Owner of the Safe Launch Control Plan / CTQ (Critical-To-Quality) / Process Control Plan and to drive Flawless launch results.
Lead for manufacturing location’s NPI/AQP Deliverables and confirms completion of the site’s quality documents required internally and by the customer during the initial launch phases of a product, in conjunction with NPI team.
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Development Stage Quality Oversight: Analyze samples, address quality issues, and drive improvement actions during product development.
Verification & Qualification: Lead design verification activities prior to design freeze and manage product qualification testing before Gate 5.
Tool & Process Validation: Perform process capability studies and support Final Tool Approval (FTAR) using Comprehensive Tool Approval Reports (CTAR).
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Self-motivated with the ability to prioritize, meet deadlines, and manage changing priorities;
Proven ability to be flexible and work hard, both independently and in a team environment, in a high pressure on-call environment with changing priorities.
Analyze complaint data to identify significant trends, present these insights to the production team to drive ongoing improvements.
Publish regular reports on product quality performance for relevant departments, providing actionable recommendations to optimize production processes.
Conduct regular product traceability exercises regarding non-conformances to identify and document root causes.
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