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.
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.
