Senior Software Validation Quality Assurance Specialist

4 weeks ago

Sunnyvale, California, United States Intuitive Full time
Job Description

At Intuitive, we are united behind our mission: to provide innovative solutions that enhance the quality of life for patients and healthcare professionals. We are seeking a highly skilled Senior Software Validation Quality Assurance Specialist to join our team.

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

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, Pharmacy, Biology, or related science or technical field.

Excellent communication and negotiation (written, verbal, and presentation) skills, and advanced problem-solving orientation and decision-making skills.

Demonstrate proficiency and thorough knowledge of computer system validation (CSV) requirements defined by applicable authorities and/or industry groups.

Thorough knowledge of quality management and CSV (GMP, 21CFR Part 11, GAMP) aspects of computer system applications.

Good knowledge of regulatory requirements (FDA, EMEA, ICH).

Experience in international and multidisciplinary environments.

Operational knowledge and experience with CS applications in a GXP environment.

Experience in CSV auditing and inspections against regulatory and benchmark quality standards.

Experience in working validation of ERP (SAP) and COTS application.

Ability to evaluate risks, define and execute action plans and propose innovative solutions to solve problems.

Ability to work on multiple projects concurrently and prioritize resources.

Motivate people and negotiate win-win solutions in a matrix-oriented organization.

Exceptional interpersonal and leadership skills.

Proven ability to develop, present and justify positions to all levels within the company.

Demonstrates attention to detail and organizational skills.

Results motivated with an excellent customer and quality focus.

Working experience on SaaS System Validation is desirable/preferred.

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