Quality Engineer

Quality EngineerClyra Medical is a growth-stage medical device company commercializing next-generation copper-iodine wound care solutions designed to improve patient outcomes globally. This is a high-impact, highly visible role offering the opportunity to build and shape quality systems from the ground up. The Quality Engineer is responsible for the implementation and maintenance of a comprehensive QA program that safeguards the quality of Clyra Medical's products and ensures regulatory compliance across the product lifecycle. The role requires a solid understanding of medical device manufacturing, design controls, and validation — and the ability to work directly with our product-specific supply chain partners and cross-functional teams spanning Product Development, Regulatory Affairs, and Operations. The Quality Engineer will represent Clyra on product and process quality matters across the full supply chain — including the Contract Manufacturer, testing laboratories, packaging suppliers, and raw material vendors — and will be responsible for supporting final product release. This role is an integrated member of Clyra's Quality, Regulatory, Manufacturing, and Product Development teams.Duties and Responsibilities:Manufacturing & Supplier QualitySupport Clyra's product-specific supply chain partners — including the Contract Manufacturer (CM), testing laboratories, packaging suppliers, and raw material vendors — in implementing new processes and managing current processes, with direct communication on quality standards and requirements.Review and approve equipment and process validations (IQ/OQ/PQ), test method validation, process changes, and nonconformances to assess impact on product reliability, process capability, and compliance.Analyze quality and manufacturing reports provided by supply chain partners and maintain comprehensive quality records across the product-specific supply chain.Ensure robust quality management across the full product-specific supply chain — including contract manufacturers, testing laboratories, packaging suppliers, and raw material vendors — through qualification, ongoing monitoring, and quality agreements.Design Control & Product DevelopmentExecute design control activities for new and sustaining product development, including risk analysis (design and process FMEA), design and process validation/verification activities, and software validation where applicable.Assist with design transfer to manufacturing, including quality control activities from production processes through final product shipment.QMS Maintenance & ComplianceMaintain and continuously improve the Quality Management System (QMS) in compliance with 21 CFR 820/QMSR, ISO 13485:2016, and applicable global standards (EU MDR, MDSAP, TGA, ANVISA).Control and maintain QMS documentation, including procedures, work instructions, forms, and records, in alignment with document control and data integrity requirements.Ensure calibration and maintenance of inspection, measuring, and test equipment in accordance with applicable standards and schedules.Support and optimize the electronic QMS (eQMS), ensuring effective configuration, user adoption, and alignment with quality processes.Audits, CAPA & NonconformancePlan, conduct, and support internal and external audits (e.g., FDA, Notified Bodies, MDSAP), including preparation, hosting, response development, and effectiveness verification.Lead investigations of nonconforming product, implement disposition decisions, and drive root cause analysis and corrective and preventive actions (CAPA).Assess complaints for reportability and support timely submission of Medical Device Reports (MDRs) and global vigilance reports (e.g., EU vigilance, Health Canada, TGA) in compliance with applicable regulations.Analyze inspection and test results, identify trends, and implement effective corrective actions.Desirable Attributes / SkillsWork effectively with people across various disciplines, including contract manufacturing partners and internal cross-functional teams.Working knowledge of regulations and standards applicable to the medical device industry, including ISO standards, FDA requirements, and country-specific guidelines. Ability to apply risk management methodologies including design and process FMEA and Risk Analysis and Management Plans.Strong organizational skills, attention to detail, and comfort working in a fast-paced growth-stage environment with evolving priorities.Experience with eQMS platforms (Greenlight Guru or equivalent); familiarity with statistical tools such as DOE and SPC is a plus.Minimum Required Education & Job Experience (Background)BS in Engineering or equivalent with 5+ years of related QA experience within the medical device spaceWorking knowledge of 21 CFR 820, ISO 13485: 2016, EU MDR 2017/745, UK MDR 2002, MDSAP (Canada SOR/98-282), Japan PMD Act, Australia TG(MD)R, and Brazil ANVISA RDC 665/2022 and RDC 185/2001.Experience supporting Class I and Class II medical devices, including non-sterile and sterile products; experience with wound care devices is preferred.Strong communication and interpersonal skills, with the ability to build effective relationships internally and externally.Strong organizational skills and attention to detail.