- documentation – writing, maintaining, reviewing and updating validation documentation, and approving validation SOPs;
- reviewing validation data, compiling reports and contributing to internal audits and external inspections as they arise;
- proposing and implementing process upgrades and efficiency improvements;
- keeping on top of advances in the field and, in particular, updates to the regulatory requirements;
- training staff on the computerized systems in line with the relevant protocols and regulations.
- technical ability such as a sound knowledge of quality principles () and computer system development lifecycles;
- keen attention to detail with natural curiosity and learning agility;
- good communication skills across a wide range of departments within the organization and an ability to engage with stakeholders to achieve the business objective;
- a resilient, agile nature with the excellent organizational ability to be able to prioritize your workload to meet deadlines and deliver in a constantly changing environment.
- Familiarity with Medical standards & FDA requirements
- Basic Knowledge of any Programming language
- Excellent documentation and Written/Verbal communication skills.
- Must be flexible, independent, and self-motivated
Senior Software Engineer - Gurugram, India - Stryker
Description
Why engineering at Stryker?
At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better. Here, you will work in a supportive culture with other incredibly talented and intelligent people, creating industry-leading medical technology products. You will also have growth opportunities as we have a culture that supports your personal and professional development.
Need another reason to apply? Check out these 8 reasons to join Stryker's engineering team:
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:
Author, Review, and Approve CSV deliverables Validation Project Plan with different Stakeholders Follow Computer Systems Validation, CSV, Processes to the author, review and approve CSV deliverables for systems. Take ownership of the CSV 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 Directly work with QA/Design/Test teams for implementing new and upgrading previously validated systems Organize and attend the meeting to discuss the status of the projects. Create and provide computer validation training programs to ensure Regulatory Compliance Assess risks related to the systems and analyze them, if necessary with the Team Review and follow SOPs to help the business process in line with FDA regulations. Follow the risk analysis process, assessment process, and change control procedures for different systems as per Stryker rules and regulations
Typical Responsibilities
Primary
What you will need:
Additional
Soft Skills
Experience: 5-8 years
About Stryker
Stryker is one of the world's leading medical technology companies and, together with our customers, is driven to make healthcare better.
The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics, and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 100 million patients annually.
More information is available at