Senior Software Validation Quality Engineer

Company Description

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.
As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

Job Description

Primary Function of Position

This position will report into Senior Manager – Product Quality Digital & CSA. The primary responsibility of this person is to represent PQ as a self-directed quality oversight on the GxP Computerized Systems Validation efforts globally across Intuitive sites around the world.

Essential Job Duties

• Maintains responsibilities for ensuring GxP computerized systems operate within the framework of regulations (GxP, 21CFR11, etc.), applicable Quality Modules, and requirements defined in local procedures.

• Provide direct oversight for computer system validation from a quality assurance perspective to ensure quality and compliance requirements are met.

• Provide guidance on CSV validation issues and discrepancies. Support investigation of CSV defects and quality records (deviation, CAPAs).

• Review CSV Validation activities including deliverables from regulatory compliance standpoint.

• Provide support to external and internal audits related to computerized system validation activities.

• Advice a cross functional team in an efficient manner, including but not limited to excellent communication and time management skills to share responsibilities and expectations, and accomplishing goals throughout timelines.

• Help, establish and sustain computer system validation global policies and standards that incorporate industry best practices and are health authority compliant.

• Partnering with internal and external teams; sharing information to increase the collective understanding of QA and Compliance programs.

• Solid knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, Part 820, Annex 11, GAMP5.

• Ensuring alignment of processes, procedures and methods across multiple organizations (internal and external).

• Ensuring systems are fully implemented and integrated with other quality management systems, site and global functions.

• Authoring and /or revising SOPs.

• Ability to provide guidance on revising validation documents and protocols.

• Administer applicable electronic systems.

• Assist as needed in audits and inspections.

• Interacts with senior internal personnel and external partners on significant matters often requiring coordination across facility locations.

• Contribute to projects related to CSV improvements.

• Support the Compliance team on computerized system audits to ensure compliant vendor/supplier management program and services.

Qualifications

Required Skills and Experience

• Requires a minimum of 8 years of related experience with a University Degree (in electrical, mechanical or system engineering, math, or physics), or 6 years of relevant experience and an Advanced Degree (in electrical, mechanical or system engineering, math, or physics)

• At least 6-8 years’ experience in the Medical Device / FDA regulated industry with 3-5 years’ experience in either Quality Assurance, Quality Management, IT Compliance or equivalent.

• Must have experience in SaMD/SiMD and IEC 62304/14971 Software Hazard/Risk Analysis

• Bachelor of Science in IT, Chemistry, Pharma