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Quality Assurance Engineer

Founded in 1987, HoMedics is a leader in consumer health, wellness, home environment, consumer electronics, and lifestyle products. Our family of brands includes HoMedics, the #1 brand in massage; HMDX Audio and JAM Audio, makers of the top-selling Bluetooth speaker in America; Ellia, premium diffusers and 100% pure, therapeutic grade essential oils; Sol Republic, a headphone company that believes in purity of sound and incredible music experiences; and The House of Marley, a high-performance audio brand developed in partnership with the Bob Marley family. We distribute our products to more than 60 countries throughout North and South America, Central America, the Asia-Pacific region, and Europe, Africa, and the Middle East.
Summary:
The Quality Assurance Engineer is responsible for providing process support in accordance with documented procedures and practices. The Quality Assurance Engineer is responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the business.
Essential Functions:
Responsible for the development, implementation, and continuous improvement of process effectiveness and efficiency
Work closely with product design and development teams, provide guidance to ensure product is properly designed, verified, validated and transferred to production or new manufacturing locations while maintaining compliance to government regulations and industry standards
Ensure Design Change Control effectiveness and compliance through the development and implementation of product and process verification and validation plans, and the development of simple yet detailed process flow diagrams that describe critical process interdependencies with respect to process inputs, outputs, risks and impacts
Review, assess and approve product design and development milestones and deliverables, including supplier quality engineering
Assist engineering/manufacturing/quality/compliance representatives to identify and mitigate compliance risks
Proactively assess risks, plan and execute audit deliverables
Interface with Senior Management and partners during inspections, audits, investigations as subject matter expert
Educate and train engineering/manufacturing/quality/compliance representatives to ensure adoption of QMS best practices.
Support continuous product and process improvement through detailed data mining, trending analysis, and failure investigations, develop and implement effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for CAPA Programs
Assist in complaints handling and investigations to identify probable root causes, and solutions, and support medical device adverse event reporting
Track defective products from the market and customers and identify root causes related to poor manufacturing process. Provide guidelines for implementation of corrective actions at suppliers and by working with Quality Assurance assets in China to monitor effectiveness of the corrections
Coordinate testing programs for returned/defective merchandise. Create metrics for identifying key indicators for sub-performing products



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