Freyr Software Services Private Limited

Job description Understanding of various SDLC methodologies (Agile, Waterfall, V) Experience in Programming or scripting languages (Java/JS etc.,). Experience in designing automation frameworks (POM, Cucumber BDD, etc.,). Generate Automation Test Strategy for applications deployed on Cloud. (Public and Private cloud) Automate scripts using a given Selenium-based framework, Serenity based BDD framework or any open-source tools. Working experience in testing Restful Webservices and APIs using frameworks or tools like POSTMAN, Rest API, etc. Experience with VAPT. Knowledge of Performance testing using Jmeter or any open-source tools. Perform Risk Analysis of Project & automation deliverables and work towards mitigation plans. Analyze requirements, perform impact analysis, and regression analysis, and communicate with stakeholders on the need for changes in requirements. Mentored and managed a testing team member to meet project goals. Experience with various testing types like Functional, Regression, UI/ Usability, Integration testing, etc., Idea on Generative AI for testing. An idea of estimation techniques for Automation testing efforts (Design and Execution). Experience in testing and test planning of CI/CD-based solutions through tools like Azure DevOps. Hands-on experience using ADO or any test management tools. Good exposure to the AWS cloud platform. Well versed with CSV and GxP process. Experience preparing and reviewing various CSV documents like Test Protocol, Test Plan, Test Strategy, IQ/OQ/PQ scripts, RTM, Test Summary Report etc., Experience working on CAPAS, Incident Management, FMEA Risk Assessment, Functional Risk Assessment etc., Role & responsibilities

Job description Responsibilities: Qualify suppliers according to company standards & management of approved supplier list per purchasing control compliance. Initiate and drives SCAPAs/NCRs to suppliers not performing/or adhering to company standards. Manage supplier change requests . Assess supplier performance on periodic basis & drive necessary action for continous improvement. Establish a process & ensures that suppliers deliver quality parts, materials, and services. Lead PPAP execution with supplier and ensure robust supplier process qualification/validation through IQ, OQ & PQ methodology. Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur. Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met. Provide pre-market quality engineering support to new product development (NPD) working in partnership with the component engineering and post-market supplier quality teams, to deliver quality parts, materials, and services, prevent defects, and allow client to provide customers with the highest quality and reliable products. Collaborates with component engineers to develop and deliver the product acceptance sampling strategy, approved supplier list coordination, supplier owned quality deployment, PFMEA,MSA, ,control plans and relevant quality tools and methodologies for new products and legacy product. Define Receiving Inspection requirements as required and associated test method validation for all internal client test methods. Conduct audits to qualify suppliers for intended use for the business as applicable. Bachelors degree in Engineering, Science, or Technical Discipline required and Minimum of 8+ years of quality systems experience. Experience in supplier management in medical domain is added advantage Strong communication skills, both oral and written. Ability to comprehend principles of engineering, physiology and medical device use. Previous customer-facing and/or project management experience is a plus. Comfortable working with international and multi-cultural department and groups in different time zones . Accurate and delivers quality work, with a sense of urgency. Ability to work well under pressure and maintain positive, enthusiastic attitude. Ability to work in a fast-paced environment .Eagerness to learn and expand responsibilities & accountability . Nice to Haves: Good interpersonal skills. Previous experience working with global team (Aerospace,Defence, Med device, automobile preferably). Ability to work effectively in a team environment and build strong working relationships. ASQ Quality certification CQE, CSQP, CQA. Working knowledge of Standard, Guidance, and Regulations. Hand on experience on Minitab tools . Exposure in auditing to FDA Quality System Regulation & ISO 13485. Lean Six Sigma Green Belt or Black Belt

Job Description Prepare, review, file, and support premarket documents for global registrations for assigned projects. Collaborate with business unit and international regulatory affairs personnel to support marketing authorizations for assigned projects. Represent Regulatory Affairs as team member of product development projects from Concept through Commercialization. Review pre-clinical, and clinical protocols and associated reports to be used in submissions for assigned projects. Develop Regulatory Strategies for new or modified products for assigned projects. Monitor and provide information pertaining to impact of changes in the regulatory environment. Communicate with regulatory agencies and/or notify bodies on administrative and routine matters. Document, consolidate, and maintain oral and written communication with health authorities Prepare internal documents for modifications to devices, when appropriate. Participate in health agency inspections & notified body audits as necessary. Author and/or review regulatory procedures and update as necessary. Review change control documents and ascertain regulatory impact for external and internal documents through formal regulatory assessments. Assist in development/maintenance of regulatory files, records, and reporting systems of systematic retrieval of information. Review promotional material, advertising, and labeling to ensure regulatory compliance on assigned projects. Minimum Qualifications: Bachelor degree in Medical, Mechanical, Electric Life Science or other healthcare related majors 4-7 years experiences for RA role in medical device and or pharmaceutical industry Good understanding for regulations and policies issued by India, US FDA and EU, and ability to interpret international regulatory requirements. Excellent written, organizational, and communication skills is required, and have a flexible and team-oriented attitude. Strong attention to details and ability to handle multiple tasks, good at planning and can work under pressure; Good at English, including reading, writing, and speaking; Good Learning attitude

Job description Minimum of 5 years of experience in Python application development. Strong proficiency in Python programming language and its ecosystem. Solid understanding of software development principles, data structures, and algorithms. Experience with web frameworks such as Angular or React. Proficiency in relational databases (eg, PostgreSQL, MySQL) and ORM libraries. Experience with version control systems such as Git. Strong problem-solving skills and ability to think algorithmically. Excellent communication and interpersonal skills. Ability to work effectively both independently and as part of a team in a fast-paced environment. Experience with cloud platforms (eg, AWS ) and containerization technologies (eg, Docker, Kubernetes) is a plus. Familiarity with Agile development methodologies.