Location
Bangalore | India
Job description
Role Purpose
The purpose o central quality analyst role is to conduct qualityaudits and perform analytics in different areas as defined by centralquality team, supporting the project teams in ensuring higher clientsatisfaction
No. of position: 1
Experience : 6 to 8 years
Location : Bangalore Sarjapur (Full time WFO)
Primary Function:
? Software Quality Management of Radiology device products to meet FDA design controls and other regulatory bodies
? Software Quality Management of GxP relevant computer systems
Position SUMMARY This position will be responsible to perform software quality management activities of medical devices (Class-2) to deliver a high-quality product that meets or exceeds customer expectations and meets FDA design controls and other regulatory bodies.
POSITION DUTIES & RESPONSIBILITIES Activities
? Software Quality Management of Software in Medical Device (SiMD) of Class-2 and Class-1 medical devices including Application software, Embedded software, Platform software, Operating system software
? Software Quality Management of Software as a Medical Device (SaMD) of Class-2 and Class-1 medical devices including Application software, Platform software including IaaS and PaaS, Cloud based software
? Responsible for ensuring development initiatives of Bayer Radiology medical devices complies and adheres to regulatory standards and guidance such as FDA Design Controls CFR 820.30, IEC 62304 ? Software in a Medical Device, IEC 82304 ? Software as a Medical Device, IEC 14971 ? Risk Management, ISO 13485 ? Quality Management Systems, 2017/745 ? European Union Medical Device Regulation (EU MDR) and various FDA guidance Pre-market submission guidelines, General Principles of Software Validation, Off The Shelf (OTS a.k.a SOUP) software use, Software as a Medical Device: Clinical Evaluation
? Conducts evaluation of software engineering activities of medical device development including requirements, software risk analysis, design, development, documentation, integration, verification, validation and release to deliver medical devices that are safe, secure and effective
? Reviews all the deliverables of medical device software lifecycle and provide clear, concise, and timely feedback to stakeholders.
? Responsible for ensuring computer system validation initiatives in Bayer Radiology organization complies and adheres to standards and guidance such as General Principles of Software Validation, Computer Software Assurance for Production and Quality System Software, FDA CFR Part 11 Compliance
? Provides guidance to cross functional teams to ensure software quality objectives are met for medical device software development
? Engaging in continuous improvement initiatives to establish Center of Excellence (CoE) in Software Assurance function such as Software Problem Resolution meetings and documentation, CAPA actions, Process and template updates and Audit support.
Requirements (Must to Have) : Skill & Competency Requirements:
? Bachelor?s degree in Computer Engineering, Electronics, Electrical Engineering or similar field
? Minimum of 5 years of relevant work experience in software engineering or quality engineering in medical device development
? Minimum of 2 years of relevant work experience in software quality management of Class 2 or Class 3 medical devices including Software in Medical Device (SiMD) or Software as Medical Device (SaMD)
? Minimum of 2 years or more of experience in interpreting industry standards for medical device development and updating processes and procedures
o Quality Management System ? ISO 13485
o SiMD ? IEC 62304
o SaMD ? IEC 82304
o FDA 21 CFR 820.30
o 2017/745 ? European Union Medical Device Regulation (EU MDR)
? Minimum of 2 years or more of experience in applying industry standards for medical device development as follows
o General Principles of Software Validation
o FDA CFR Part 11 Compliance
? Must be able to handle multiple tasks/projects and manage priorities accordingly.
? Technical writing ability ? clear and concise writing easily understood by multiple audiences (auditors, peers, etc.)
Preferences (Good to Have): ? 2 or more years of relevant work experience in various phases of software development lifecycle including requirements, architecture, design, development, testing, release, deployment, post-launch support activities
? 2 or more years of programming experience in any of the following languages C, C#, Java, React JS, Angular
? Working knowledge of tools including JIRA, AWS, GitHub, Rational Quality Manager, DOORS Next Gen
? Working knowledge on OS such as Windows, Linux flavors
? Demonstrated ability working in a matrix/hybrid organization structure
? Ability to troubleshoot and make quick knowledge and experience-guided decisions
? Excellent written and oral communication
? Excellent people skills, ability to partner well, good team camaraderie
? Proficient with Microsoft Office tools especially MS Word, MS Excel, MS PowerPoint, MS Project, and other management tools
Competency Levels
Foundation
Knowledgeable about the competency requirements. Demonstrates (inparts) frequently with minimal support and guidance.
Competent
Consistently demonstrates the full range of the competencywithout guidance. Extends the competency to difficult and unknownsituations as well.
Expert
Applies the competency in all situations and is serves as a guideto others as well.
Master
Coaches others and builds organizational capability in thecompetency area. Serves as a key resource for that competency and isrecognized within the entire organization.
- Behavioral Competencies
- Analytical Skills
- Execution Excellence
- Client centricity
- Stakeholder Management
Deliver
No. | Performance Parameter | Measure |
1. | Quality Standards | Timely generation of reports, dashboards, insights to therespective team Accuracy of the data Feedback from the project teams on the insights Quality of insights shared with the team |
Medical Regulatory and Process Standards
Job tags
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