Senior Software Engineer - CSV

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

• 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.

What you will need:

• technical ability such as a sound knowledge of quality principles (e.g. ISO 13485) 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.

Additional

• Familiarity with Medical standards & FDA requirements
• Basic Knowledge of any Programming language

Soft Skills

• Excellent documentation and Written/Verbal communication skills.
• Must be flexible, independent, and self-motivated

Experience: 5-8 years