Quality Engineer I

Position Summary The Quality Engineer I position supports quality assurance activities to ensure compliance with applicable regulatory standards (such as FDA and ISO 13485) and internal quality systems. This entry-level role focuses on collaborating on quality projects, process improvements, and data analysis to maintain and optimize product quality throughout its manufacturing lifecycle. Essential Duties and Responsibilities • Reviews and investigates product issues and/or customer complaints or other nonconformities, including quality system assessments, root cause determinations, and recommends corrective and preventive actions where required. • Provides quality support for products and project development. • Acts as a quality representative for quality issues in transfer products. • Conduct routine walkthroughs (Gemba) in manufacturing areas to identify opportunities for improvement. • Provide feedback to manufacturing engineering to reduce rejects and non-conforming materials. • E...

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