Sr. Manager, Quality Management Systems
Intuitive

Sunnyvale, California

This job has expired.


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:

The Digital Engineering Group designs, builds, deploys, and supports both medical device and non-medical device software, data infrastructure, web portals, hardware, web applications and services to collect and analyze medical device machine data from thousands of systems deployed world-wide.
The ideal candidate for the position of Senior Manager, Digital Quality Systems will have experience in the design, development, rollout, and continued management of a regulated Quality Management System (QMS) and building a team which to support. This position would act as a leader in the Digital Quality organization and is responsible for all aspects of development and management of the overall non-medical device quality system and continued compliance and improvement..

Roles and Responsibilities:

This position has responsibility and authority for:

  • Development, implementation, maintenance, and improvements to compliance of applicable regulatory requirements by maintaining an effective quality management system under ISO 9001
  • Building a team to support the various development and maintenance of the quality system
  • Coordinate audits by the Notified Body and / or other regulatory bodies and third parties, and coordinates responses to applicable audit findings
  • Collaborate with other Quality peers to implement digital solutions to support the Quality Management System
  • Assessing the company requirements in all facets of quality management, from product design control through production to customer service, corrective actions, and audits
  • Provide support to internal functions in the application, maintenance and improvement of quality systems, procedures, and department specific processes
  • Prepare quality/performance reports and metrics for the QMS
  • Ensure efficient and effective processes and tools are established for compliance with ISO and other standards and requirements
  • Coordinate the communication and review of quality data in Management Review and other forums
  • Must be able to work with Product development teams, Operations, SQA, Manufacturing, and support groups at all levels
  • Work closely with Digital Quality leaders to define and drive the NMD QMS vision and roadmap
  • Prepares reports and other information for readouts to Executive Management

Qualifications

Skill/Job 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 have:

  • Minimum Bachelor's degree in General Business, Engineering, Science a related field or 8+ years of related experience
  • Ability to lead various activities and recommend process improvement opportunities for multiple concurrent projects
  • Strong understanding of ISO 9001, 13485, FDA 21 CFR and other relevant standards
  • Able to multi-task in a dynamic, fast-paced environment
  • Ability to build and lead a team of highly qualified technical quality engineers
  • Strong talent development and leadership skills
  • Strong commitment to quality and ability to work closely and communicate effectively with developers and project managers across multiple teams
  • Strong knowledge of medical devices, combination products and NMD used within and outside of a clinical environment.
  • Experience working with Digital applications and services
  • Solid understanding of Modern SDLC processes and development methodologies
  • Working knowledge of software engineering best practices for the full software development life cycle, including modern development methods, code reviews, source control, build and release processes, continuous deployment, and test suite development and maintenance
  • Demonstrated knowledge across multiple aspects of quality systems and quality engineering
  • Experience and understand in Design Control and Design Validation
  • Strong interpersonal skills and able to work with various cross functional teams to deliver high quality products
  • Attention to detail and organizational skills
  • Willingness to learn and implement new processes
  • Self-motivated, independent, and proactive
  • Excellent communication (written, verbal and presentation) skills, and advanced problem-solving orientation and decision-making skills.
  • Experience working in Agile/Scrum models Ability to critique work of self and others constructively
  • Excellent documentation skills and ability to communicate effectively at all levels of the organization
  • Possess time management, prioritization skills and ability to perform project work breakdowns and project plans
  • Eligibility to legally work in the united States
  • Some travel may be required (no more than 10%)

Additional Information

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 : Day

Travel : 10% of the time

Travel Requirements:10% of the time Shift:Day


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