Quality Specialist

Company DescriptionZetrOZ Systems is a healthcare technology company based in Trumbull, CT, specializing in soft tissue healing therapeutics. The company's innovations are designed for acute and chronic musculoskeletal conditions to enhance tissue recovery, accelerate natural healing processes, and relieve pain. ZetrOZ Systems serves millions of patients globally with proprietary medical technology platforms.Role DescriptionThis is a full-time on-site role for a Quality Specialist at ZetrOZ Systems in Trumbull, CT. The Quality Specialist will be responsible for tasks related to quality control, auditing, assurance, and communication. The day-to-day responsibilities include ensuring quality standards are met, conducting audits, maintaining documentation, and communicating quality issues effectively.ResponsibilitiesThis position is primarily focused on maintaining and improving quality processes and leading inspection of manufacturing ultrasound systems and accessoriesProcess Validation: IQ/OQ/PQ and developing protocols for new product manufacturing validationSupplier Quality: Manage supplier changes and work with Operations/Engineering to evaluate change impact to product performance. Improve supplier scorecard and track performance (e.g. risk management related to supplier/supply chain, site inspections, assessmentsQuality Control: Develop and implement quality control plans for single use products and electronic ultrasound systems and utilize statistical techniques to analyze and improve manufacturing output.Develop and maintain inspection and quality control proceduresCorrective Action: Manage CAPA initiatives to drive continuous improvement.Project Leadership: Manage improvements across multiple product linesTechnical Documentation: Maintenance of records for compliance with FDA regulation and ISO 13485 standardQualificationsMinimum of 4 years experience in medical device manufacturingExperience with intake inspectionKnowledge of FDA regulations and ISO 13485 requirementsProficiency in statistical analysis methodsKnowledge of medical device validation requirementsProficiency in reviewing engineering drawing and design changes for risk analysis and impact on product Bachelor's degree in a related fieldCompensationCompetitive full-time salary based on CT-Pay bands401(k) and Profit ShareHealth InsurancePaid Vacation Quarterly Performance Bonus

Created: 2025-01-30