Senior Quality Engineer (Software Quality)
Publication date:
25 June 2024Workload:
100%Contract type:
Unlimited employment- Place of work:Gurugram
Who we want:
- Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
- Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
- Curious learners. People who seek out cutting-edge research and information to expand and enhance their ability to develop new ideas into reality.
- Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.
What you will do:
- Lead Risk Management activities throughout the product development life cycle. Risk assessment for medical devices as per ISO 14971.
- Author Risk management plan and report, Risk Table creation & Analysis, FMEAs.
- Partner with Product Development to perform risk evaluation of product design and to define appropriate risk controls to ensure safe and effective product is developed.
- Conduct and/or participate in DHF Reviews, Design Reviews and Phase Gate reviews.
- Review and approve tangibles throughout SDLC. Ex. Software Requirements, Design, test plans and reports.
- Take ownership of the CSV (Computer System Validation) and Equipment Qualification effort on different Hardware and Software Tools and fixtures being used across different Teams.
- Author, Review, and/or Approve CSV deliverables (Project plan, requirements, risk management, validation protocol etc.).
- Co-ordinate with the different teams for understanding their requirements and validate the system accordingly Review and identify validation deviations and resolve deviations with appropriate corrective/preventive actions.
- Work with cross function team (QA/Design/Test teams) for implementing new and upgrading previously validated systems.
- Organize and attend the meeting to discuss the status of the projects.
- Provide computer validation training and guide the team to ensure required process are followed to determine risks related to the systems and analyze them.
- Follow the risk analysis process, assessment process, and change control procedures for different systems as per Stryker rules and regulations.
- Develop quality assurance documentation to support regulatory submissions.
What you will need:
- Minimum 2-6 years of experience as a Software Quality Engineer (Software QE) in a regulated design environment. Prefer experience with medical device product development life cycle, including risk management and design/ process verification & validation.
- Knowledge of FDA QSRs, ISO 13485 Design Control Procedures, IEC 62304 and ISO 14971, ISO 62366.
- Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA) and Root Cause Analysis
- Exposure to Software development life cycle (SDLC) & validation process.
- Able to do risk assessment for medical devices as per ISO 14971 and Lead Risk Management activities throughout the product development life cycle.
- Good Understanding of Computer System Validation and/or Equipment Qualification process.
- Strong experience in Documentation, Review & Reporting areas.
- Demonstrated ability to test, review defects and inspect software design.
- Participate in internal and external compliance audits.
- Demonstrated ability to advocate product excellence and quality.
- Demonstrated ability to effectively work cross functionally with other departments including Advanced Operations, Product Development, Regulatory and Marketing.
- Demonstrated problem-solving and troubleshooting skills.
- Demonstrated interpersonal and communication skills.
- Demonstrated a positive, energetic approach to teamwork.
- Demonstrated ability to learn quickly and multi-task.
- Demonstrated ability to respond to the urgent needs of the team, with proven track record of meeting deadlines.
- Computer proficiency with MS Office applications.