Job Description
Desired skills:Software QA Design Engineer, Jira, CFR, QMSPosition Overview:The Software QA Design Engineer will play a crucial role in ensuring the quality and safety of our medical device software. This position involves working closely with the development and manufacturing teams to validate and verify software, ensuring compliance with industry standards and regulations. The ideal candidate will have a strong background in Quality Management Systems (QMS), risk management, and software validation and verification (V&V).Develop and implement software QA processes in compliance with IEC 62304, ISO 13485, ISO 14971, and relevant CFR standardsEnsure effective risk management practices are in place for validation and manufacturing processesPerform verification and validation (V&V) of software, ensuring it meets all regulatory and quality requirementsUtilize Six Sigma methodologies to improve software quality and process efficiencyManage and maintain Quality Management Systems (QMS) by industry standardsWork collaboratively with cross-functional teams, including software developers, manufacturing engineers, and regulatory affairsUse Jira for tracking and managing software defects and enhancementsProvide expertise in regulatory compliance, particularly with medical device software standardsQualifications / Requirements:Bachelor's degree in Computer Science, Engineering, or a related fieldMinimum of 5 years of experience in software quality assurance, preferably in the medical device industryExtensive knowledge of IEC 62304, ISO 13485, ISO 14971, and relevant CFR standardsStrong understanding of risk management principles and practicesProficiency in Six Sigma methodologiesExperience with Quality Management Systems (QMS)Hands-on experience with Jira for defect tracking and project managementExcellent analytical and problem-solving skillsStrong communication and interpersonal skills, with the ability to work effectively in a team environmentComprehensive health and dental insurancePension planOpportunities for professional development and career advancementCollaborative and innovative work environment Reperio Human Capital acts as an Employment Agency and an Employment Business. Jade Molloy is recruiting for this role. Why not send us your CV to be kept up to date with the latest jobs or to have an initial discussion with one of our Consultants.Sign up to our newsletter to receive information about the latest jobs we have on offer. #J-18808-Ljbffr