A leading medical device manufacturer is seeking an experienced Quality Engineer to join its consumables team. This hands-on, strategic role will focus on driving quality excellence across production, supply chain, and R&D functions.
As Quality Engineer Key Responsibilities:
* Develop and implement quality standards, procedures, and control plans
* Lead root cause analysis and corrective/preventive actions (8D, FMEA, CAPA)
* Manage testing protocols and ensure compliance across new and existing products
* Collaborate with suppliers on quality standards and conduct supplier audits
* Maintain accurate quality records and ensure compliance with ISO 9001, GMP, and Six Sigma principles
Requirements:
* Degree in Engineering, Quality, or related field
* 5+ years' experience in quality engineering, ideally in manufacturing
* Strong knowledge of Six Sigma, SPC, CAPA, and ERP systems
* Excellent communication and cross-functional collaboration skills
* CQE, Six Sigma Green/Black Belt, or ISO Lead Auditor preferred
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