Specialist I - Q&R-QA/QE

Description: Specialist I - Q&R-QA/QE,Job Responsibilities: Participates in the development and maintenance of comprehensive software quality documentation, including Software Requirement Specifications (SRS), ensuring they are accurate, up-to-date, and fully compliant with relevant standards and regulatory requirements throughout the software lifecycle, working under general supervision. Executes the assessment of software designs, including reviewing test and performance data, to ensure they meet quality, safety, and regulatory standards, while identifying and addressing quality engineering deficiencies to embed quality within the design. Conducts in-depth root cause analysis for software quality issues, employing problem-solving techniques to resolve deficiencies and improve software design processes, ensuring that quality is integral to the development process. Guides validation of key software design inputs such as usability, reliability, performance, localizability, safety, privacy, and cost to ensure they meet customer and regulatory requirements, supporting the delivery of high-quality software products. Ensures effective oversight of the execution of software quality plans and associated risk management activities throughout the software lifecycle, ensuring that all design-related activities are managed according to defined processes. Utilizes post-market analytics and statistics to monitor software performance in the field, providing feedback to manufacturing, suppliers, and design teams, while initiating corrective actions or field actions when required to maintain software quality. Participates in the development of comprehensive Software Quality Plans that cover all stages of the software lifecycle, from design through to post-market, supporting the design of these plans and ensuring adherence to quality and regulatory standards. Possesses and applies working knowledge of relevant global regulations, requirements, and standards, ensuring that all quality activities and software design processes comply with applicable regulatory requirements, facilitating compliance throughout the software development lifecycle. Provides guidance to meet schedules, resolve technical problems, and manage performance requirements, including mentoring on quality engineering practices, regulatory compliance, and QMS processes. Reports key software quality metrics, ensuring these metrics are aligned with business objectives and regulatory expectations, while communicating quality-related performance indicators to relevant stakeholders. Minimum required Education: Bachelors Degree in Computer Science, Computer Applications or equivalent Minimum required Experience: Around 8 to 12 Years of Professional Experience , with at least 3 to 4 Years in medical device domain (software domain preferred) Minimum required Certification: N/A Preferred Education: N/A Preferred Experience: -Knowledge of relevant external standards for Quality Management Systems for medical devices (e.g. ISO13485, ISO 14971, MDD/MDR, FDA-QSR 820/ QMSR, IEC62304, IEC62366) -Working experience in Agile methodology enabling projects/ programs within regulatory compliance -Knowledge of (software) processes and procedures -Qualified Auditor of Quality Systems/ Experience in MDSAP audit as auditor/ auditee (Preferable) -Excellent communication skills -Project management knowledge and skills. -Knowledge of product creation and (software) development methods & tools -Experience in using problem solving tools -Knowledge of external regulations and standards relevant for our products -Knowledge on Product Quality Engineering and metrics/ KPIs Preferred Certification: CSQA/ISTQB certification Preferred Skills: Design Quality Management Data Analysis & Interpretation Design for Quality (DFQ) Root Cause Analysis (RCA) CAPA Methodologies Regulatory Requirements Privacy, Safety and Security Risk Assessment Technical Documentation Continuous Improvement Software Development Life Cycle (SDLC) Product Quality and Reliability Defect Management Design Verification Planning Design Validation Planning Product Test Design,Cost reduction by changing vendor / Replacement for contingent employee Srinivasan M Level of Experience India Additional Details Minimum required qualifications : Minimum required Education: Bachelors Degree in Computer Science, Computer Applications or equivalent/ Vocational Education. Minimum required Experience: No prior experience required with Bachelors OR minimum 4 years of experience in Software Quality Engineering or equivalent with Vocational Education. Minimum required Certification: N/A Job title: One sentence description of role Your role: The greater impact of this role. Detail elements of the team and stakeholders for this role. What are the professional and personal opportunities for development within this role? From (benefit 1) to (benefit 2), a career at Philips comes with all sorts of wonderful benefits. Be sure to speak to your recruiter about benefits in your region. Youre the right fit if: (4 x bullets max) 1. Experience. 2. Skills. 3. Education. 4. Anything else. How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the companys facilities. Field roles are most effectively done outside of the companys main facilities, generally at the customers or suppliers locations. Indicate if this role is an office/field/onsite role. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we wont stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others. Learn more about our business. Discover our rich and exciting history. Learn more about our purpose. If youre interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here. Level of Experience India : d. 6 - 8 Years Job Profile Name : Software Design Quality Engineer 50 Job Grade : 50