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Computer Validation Specialist at Intuitive Surgical, Inc. in Sunnyvale, California

Posted in General Business 15 days ago.

Type: Full-Time

Job 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.

Roles and Responsibilities:

This position has responsibility and authority for:

  • Development and approval of Validation Plans, IQ, OQ Protocols, Trace Matrices, Risk Assessments and Validation Summary Reports
  • Analysis of current business processes to translate development documents into user requirements and functional design specifications
  • Establish validation standards, develop testing protocols, prepare equipment, document test results and maintain records for later analysis
  • Documentation and remediation of deviations resulting from validations/qualifications.
  • Utilizes established protocols to perform validation and qualification tests and provide detailed and accurate analysis of test results, identifying validation failures and areas of non-conformance
  • Provide assistance and guidance in training co-workers on validation protocols and operating procedures.
  • Oversees external validation resources that may be used in the validation project
  • Author assigned Operating Procedures (SOPs & DOPs) and Policies to ensure compliance with Company policies and federal regulations.
  • Support regulatory agency inspections/audits, as required.
  • Must be familiar with cGMPs and current industry guidelines.
  • Interfaces between various internal and external functional areas to assure successful integration and completion of validation activities in overall project schedules.
  • Applies quality standards, policies, procedures, and knowledge of current industry/regulatory standards for validation implementation, execution and completion
  • Maintains awareness of regulatory requirements

Competency Requirements: (Competency is based on: education, training, skills and experience.)

In order to adequately perform the responsibilities of this position the individual must:

  • Minimum Bachelor's degree (B.S.) in related field or equivalent.

  • Minimum Five year's related experience or equivalent in a Medical Device or FDA Regulated industry.

  • Knowledge of fundamental cGMP concepts and FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, ISO 13485:2003 and ISO 9001 Standards

  • Strong knowledge of FDA Regulated manufacturing processes, process validation, computer and equipment validation, and GMPs.

  • Ability to develop clear, concise, and timely oral and written reports. Excellent written and oral communication skills

  • Ability to work on complex projects with general direction and minimal guidance.

  • Ability to handle multiple projects and meet deadlines.

  • Ability to manage priorities and workflow. Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.

  • Ability to work independently and as a member of various teams and committees.

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.

Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Shift : Shift 1 - Day

Travel : No

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