Company DescriptionAt 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.
Primary Function of Position:
The Global Corporate Auditor will support the execution of an efficient and effective internal audit program. They will support the internal and external audit program to ensure compliance to the regulatory requirements and standards of the Quality Management System (QMS). This individual will have a clear understanding of applicable laws and regulations in order to identify and manage the company's risks appropriately. They will use Quality Auditing principles, tools and techniques to support quality systems and processes aligned with the overall Company strategy and mission affecting continuous process improvement. They will ensure effective closure of audit findings, by working with cross functional and varying level of departments/business partners to ensure comprehension, development, and execution of corrective/preventive action and evaluation of effectiveness checks. They will assist with gap assessments including working with functional area owners to close regulatory gaps. They will continually educate the organization on effective compliance systems, processes in alignment with applicable laws and regulations. They will support the quality and regulatory improvement projects and provide insight for long-term strategic QMS improvement.
Roles & Responsibilities:
- Conduct internal audits across all sites. May also coordinate internal audits and provide oversight to external contractors.
- Support external audits or regulatory inspections across global sites
- Complete gap assessment for regulations, regulatory standards, and corporate procedures
- Train company employees on Quality System Regulations and quality system foundational principles
- Work together with strategic partners across global sites to assure compliance with all company procedures and regulatory requirements.
- Support Quality System projects for new and changing regulatory requirements
- Serves as the lead coach/consultant to educate internal customers on regulatory compliance processes and regulations
- Create, approve, and maintain company quality documents, such as quality procedures, work instructions, and forms
- Support CAPA program as audit findings are an input to the CAPA process. Review, approve, provide feedback on CAPA documentation as assigned
- Analyzes quality data and provides compliant, pragmatic guidance to support Regulatory Compliance activities including responses to agency requests for information and analyses to support quality improvement projects.
- Prepare responses to regulatory audit observations. Ensure that responses are clear, comprehensive, accurate, and well written to mitigate potential for further regulatory actions.
- Provide data to support; Risk based audit schedule, process analysis, process controls, FDA trending and finding history, and needed process improvements activities
- Support implementation and continuous improvement of the audit programs, auditor qualification programs, and company-wide inspection readiness.
- Support, consult, train, and lead quality improvement projects
- Provide Quality System Consultation
- Support new site integration activities across global sites
- Assist in the development of Quality System Metrics and KPIs
Skills, Experience, Education, & Training:
- Minimum Bachelor of Science degree in Technical, Engineering or Science related field.
- ISO certified lead auditor (ISO 9001, ISO 13485 and/or ISO 14155 or ASQ CQA)
- Minimum 2+ years of FDA /ISO 13485 lead auditing experience,
- Minimum 7 years' of experience in quality in the medical device or pharmaceutical industry
- Experience as a Quality Engineer, Software and Validation experience is an asset
- Strong knowledge of EU-MDR, ISO 13485:2016; Medical Device Single Audit (MDSAP), and 21 CFR 820 requirements, familiarity with EU-MDR, , Health Canada, and other international regulatory requirements
- Previous front room experience participating in notified body and FDA inspections
- Familiarity with GMPs related to Combination and Drug Products
- Ability to work on virtual teams, remote management; self-directed
- Ability to be a team player and a partner to the cross- functions teams; be part of the solution and demonstrate ability to use risk-based judgment.
- Critical thinking skills and a passion to work in a fast-paced industry with complex/cutting edge technology
- Strong organizational, written and verbal communication skills, remote working apps and the proven ability to prioritize tasks effectively in a deadline-driven environment
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.
Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.
We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.
Base Salary Range Region 1: $112,900 USD - $162,500 USD
Base Salary Range Region 2: $95,900 USD - $138,100 USD
Travel: 25% of the time
Workplace Type: Purposeful Onsite - This job requires being onsite for leader-defined events and activities which could be monthly/annually. Onsite frequency may increase based on business need.