Software Validation Lead
1 week ago
We are seeking a highly skilled Software Validation Lead to join our team at Intuitive Surgical. As a key member of our quality assurance team, you will be responsible for ensuring the compliance of our computerized systems with regulatory requirements and industry standards.
Key Responsibilities:
- Oversight of all GxP regulated computerized systems at all applicable points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures with Data Integrity requirements.
- Providing oversight of validation activities, leading the development and approval of validation documentation, risk assessments, working with project teams to determine which elements should be validated and conducting impact assessments of proposed changes to computerized systems.
- Performing and/or directing GxP computerized system validation projects in compliance with 21 CFR 820, ISO 13485, ISO 62304, 21 CFR Part 11, Annex 11, and Data Integrity.
- Ensuring that GxP systems meet intended uses and comply with applicable regulations, current industry practices, and Intuitive Surgical policies and procedures.
- Supporting systems and new product introduction by serving as a Quality resource, providing expertise, problem-solving, and strategies for problem prevention.
- Participating as the Product Quality representative in project team activities and process design to ensure cGxP compliance and interdepartmental consistency within the validation program.
- Assuring compliance to all applicable regulations by proactively interpreting regulatory and compliance requirements as related to validation.
- Coordinating and providing training and/or opportunities for career development of others.
- Driving a culture of continuous improvement by employing Practical Process Improvement concepts and reporting metrics and communicating internally to diverse audiences.
- 8+ years’ hands-on experience in Software Design/Quality Engineering in a medical device/Pharma industry with a focus on GxP systems.
- Hands-on experience with agile scrum process and tools (Agile/JIRA/Atlassian/Polarion).
- Hands-on experience with Software Validation following 21 CFR Part 11, ISO 62304, and applicable medical device QMS & software Life Cycle process.
- Working knowledge of 21 CFR 820, ISO 13485, ISO 14971, 21 CFR Part 11, GAMP5, electronic record and electronic signature.
- Experience working on low and high-risk software applications using a scalable approach to the SDLC practices and the QMS.
- Ability to work in a geographically diverse business environment.
- Attention to details and Quality are critical to success.
- Excellent organizational, interpersonal, and verbal and written communication skills, with the ability to deliver quality outputs under minimum supervision.
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