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Quality Engineer

3 months ago

Delaware, United States Attindas - US Full time

Description Position at Attindas - US Attindas Hygiene Partners designs, manufactures, and markets absorbent hygiene products. The company sells adult incontinence and infant diapers, among other products, into the healthcare, retail, and direct-to-consumer channels under brands including Attends, Indas, and Comfees as well as a wide range of private label brands for retailers. Mission: We champion health, dignity and comfort. Vision: To be a global leader in absorbent hygiene by meeting consumers' diverse needs through effective, affordable and widely available personal care solutions. Our Values: Caring, Agile, Innovative, Unique, Personal, Genuine Job Summary: The QA Engineer II is responsible for ensuring QA System compliance and capability through ownership, development, implementation and continuous improvement of quality systems within the site. The QA Engineer II is responsible for the daily QA lab activities and staffing.Key responsibilities: Development, Implementation and Management of Quality Systems at the Site. Owner of the sites quality systems to ensure compliance to the corporate quality system, site procedures and ISO 13485. Document Control Site System OwnerInternal Audit Program OwnerMock Recall & Traceability Process OwnerCorrective & Preventative Action System OwnerQMS Training Lead for the siteElectronic QMS System Key User for the siteOthers as assigned by QA managerProvides updates and ongoing health checks of the processes.Supports plant goals by implementing systems to support continuous improvement. Leads/Supports All Internal and External Quality Audits.Internal Audit OwnerGMP Monthly Inspection (Coordination and Metrics)Leads / Supports External Audits as required. Enhancing Operations Quality Capability & Ownership through Training, Coaching and SupportingProvides site wide quality systems training, coaching and support Leads the transfer of identified quality systems to the QA Technicians by providing system development, training and ongoing coaching. Backup product release support as needed. Serves as the backup to the QA manager as needed. Continuous ImprovementLead continuous improvement activities including transferring from a heavy product testing to online capability controls. Work across other sites to standardized best in class approaches / processes.Leads Lab Operations and Supervises/Manages Lab Personnel. Perform other duties as assigned.Required Qualifications/Professional ExperiencesBachelor's degree in Engineering.5-7 years of experience implementing and managing quality systems. Experience developing and implementing site quality systems compliant with corporate requirements.Work effectively with teams and individuals.Strong IT skills, including MS Word, Excel, PowerPoint, and related MS Office applications. 1-3 Years Management and/or Supervisory Experience Preferred Qualifications/Professional Experiences/Years of Experience: Prior experience in a regulated manufacturing environment (Medical, Pharma or Food)Advanced Microsoft office skills (excel, word).Experience developing and implementing quality systems.Green Belt Six Sigma Training. Attindas is an equal opportunity employer. Qualified applicants will be considered without regard to age, race, color, sex (including gender identity or expression, sexual orientation, and pregnancy), marital status, religion, national origin, genetic information, disability, or veteran status.