Urgent! Medical Device Software Quality Engineer Job Opening In Blue Ash – Now Hiring Tata Consultancy Services
• Technical/Functional Skills Experience in Quality Engineering or Assurance with a focus on software testing, design control of software development, software verification and validation.
Experience Required •Minimum 2 years of professional work experience in Quality, R&D, New Product Development, Electrical Engineering, Systems Engineering, Software Engineering, or Computer Science.
•Experience in Quality Engineering or Assurance with a focus on software testing, design control of software development, software verification and validation.
•Application of Design Control fundamentals •Knowledge of applied statistics and experience with statistical software applications (., Minitab® and/or ReliaSoft) •Knowledge of product/process Risk Management (DFMEA/PFMEA or Gage R&R Analysis, FDA and ISO standards) including cybersecurity assessment.
•Ability to identify and simplify complex issues, as well as demonstrated ability for proactive, organized, and systemic approach to making decisions and resolving issues •Ability to work in a team and demonstrate good interpersonal, organization, and oral/written communication skills •Quality Engineering Certification, Software Quality Engineering Certification (., ASQ CQE, ASQ CSQE) •Certification (., Black belt) in one or more of the Process Excellence roadmaps (., DMADVV, DMAIC, or Lean) Roles & Responsibilities•The Quality Engineer (Software/Systems) will develop, maintain, and continuously improve the software based medical device and digital products quality capability, ensure compliance with procedures and regulatory expectations for existing and new software medical devices and digital products, and develop and optimize programs that focus on maintaining regulatory and compliance requirements while using risk-based, scalable approaches •Advise and educate key functional partners and management on medical device and digital product requirements, standards and regulations such as IEC 62304, ISO-13485, 21 CFR 820, and EU MDR •Plan, lead, and execute continuous improvements to the software quality processes •Provide independent design review for other software medical device programs •Ensure inspection readiness and maintain CE marks for existing software medical devices •Employ key company processes to support projects and quality system processes as required by the position, including following quality procedures and add to the quality system documentation, understanding expected outcomes of key quality processes, and creating or updating risk documents via New Product Development, New Process Introduction, and Lifecycle Engineering.
•Utilize Risk management and risk mitigation tools and practices (for example, mistake pr oofing, critical control points, failure modes and effects analysis).
•Conduct reliability assessments of product design.
•Perform root cause investigations using various problem-solving techniques and tools and assesses effectiveness of corrective actions.
•Develop and validate test methods in equipment, process, and product qualifications/validations.
Design and execute Measurement Systems Analysis (MSA).
•Implement and/or maintaining production and process controls using appropriate techniques (for example, process capability measures, statistical process controls, and process performance metrics).
Generic Managerial Skills •Understanding of Engineering principles, Product designs, Product Lifecycle, Design Specifications, Product Requirements and Product mechanisms •Understanding of Medical Devices and related Regulatory Standards •Results driven – consistent delivery of targets, deadlines, and commitments.
•Decision quality - sound judgement whilst thinking laterally and innovatively.
•Collaborative and ability to influence throughout the organisation •Leading people through Change •Managing Self and organization of others •Learning agility and a continuous improvement orientation •Proficient in IT, Microsoft Applications •Fluent English (verbal and written) •Able to represent the system to a wide array of individuals (management, technicians, engineers, etc…) and explain at their technical level.
•Must be able to correlate broad array of requests and distill into a single requirement.
•Must be able to navigate complexities of technical ownership with a fast-paced business.
•Able to understand and negotiate trade-offs in timeline, budget, and requirements while maintaining quality of work and data integrity of system.
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Unlock Your Medical Device Potential: Insight & Career Growth Guide
Real-time Medical Device Jobs Trends in Blue Ash, United States (Graphical Representation)
Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph below. This graph displays the job market trends for Medical Device in Blue Ash, United States using a bar chart to represent the number of jobs available and a trend line to illustrate the trend over time. Specifically, the graph shows 66394 jobs in United States and 33 jobs in Blue Ash. This comprehensive analysis highlights market share and opportunities for professionals in Medical Device roles. These dynamic trends provide a better understanding of the job market landscape in these regions.
Great news! Tata Consultancy Services is currently hiring and seeking a Medical Device Software Quality Engineer to join their team. Feel free to download the job details.
Wait no longer! Are you also interested in exploring similar jobs? Search now: Medical Device Software Quality Engineer Jobs Blue Ash.
An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at Tata Consultancy Services adheres to the cultural norms as outlined by Expertini.
The fundamental ethical values are:The average salary range for a Medical Device Software Quality Engineer Jobs United States varies, but the pay scale is rated "Standard" in Blue Ash. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.
Key qualifications for Medical Device Software Quality Engineer typically include Engineers and a list of qualifications and expertise as mentioned in the job specification. Be sure to check the specific job listing for detailed requirements and qualifications.
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Here are some tips to help you prepare for and ace your job interview:
Before the Interview:To prepare for your Medical Device Software Quality Engineer interview at Tata Consultancy Services, research the company, understand the job requirements, and practice common interview questions.
Highlight your leadership skills, achievements, and strategic thinking abilities. Be prepared to discuss your experience with HR, including your approach to meeting targets as a team player. Additionally, review the Tata Consultancy Services's products or services and be prepared to discuss how you can contribute to their success.
By following these tips, you can increase your chances of making a positive impression and landing the job!
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