Anumana
Location
Bangalore | India
Job description
Senior Quality Engineer (ISO 13485:2016, 14971:2019):
Responsibilities: Participate in cross functional teams supporting software design and development lifecycle Ensure development projects meet defined development process requirements of FDA 21 CFR 820.30, EN/ISO 13485:2016 and MDR 2017/745. Ensure software development is compliant with IEC 63204:2015 standard. Support design verification testing including; providing guidance in developing and validating test methods, reviewing and approving verification records. Facilitate and oversee the development of risk management activities for projects in compliance with ISO 14971:2019. Ensure timely completion of all Quality Assurance deliverables to support the design and development projects. Support the developmental design change process for each project's specifications. Ensure the quality of all design and development documents and records, so that they readily support regulatory submissions. Support internal and external audits as required. Support Quality Management System development and updates as required. Support Quality functions such as CAPA management, Supplier and Complaint management as required. Support non-product software tool evaluation and validation process. Support project based activities through leading or supporting cross-functional initiatives. Other related duties, as may be assigned. Education: Bachelor’s Degree or equivalent in an Engineering or other scientific discipline or combination of education and relevant work experience. Qualifications 5+ years of SaMD or SiMD medical device or relevant quality experience. Thorough understanding of 21 CFR 820, ISO 13485, ISO 14971, EU MDR and IEC 62304 requirements. Skills: Advanced analytical and problem-solving including application of statistical methods. Tenacious attention to detail. An approachable individual who provides a high level of teamwork and cross-functional collaboration. Outstanding communication and interpersonal skills within all levels of the organization Ability to manage projects efficiently and effectively.Job tags
Salary
