Clinical Quality Auditor
Intuitive

Job Info

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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

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.

 

 

Primary Function of Position:

 

 

 

 

The Clinical Quality (CQ) Auditor will actively participate in and support the daily operations of Clinical Quality Audits aligned with the Regulatory Compliance Internal Audit program. The individual will collaborate cross-functionally within the organization to conduct various internal and external audit activities (Investigator Sites and Vendors) as determined by Intuitive audit plans or as required by government / regulatory agencies on a global basis. The individual will provide strategic leadership to ensure an up-to-date understanding of clinical research best practices, applicable laws and regulations to ensure company's risks are identified and managed appropriately.

 

 

The individual will add contribute to enhancement of ISI's internal audit controls and operating efficiencies, and other processes necessary to ensure compliant practices to mitigate the Company's risks. The candidate should have strong knowledge of professional audit practices, clinical research regulations (USinter-state & global),  sound decision making and communication skills. Facilitate and lead inspections and audits required by government / health authorities regulatory agencies on a global basis.  

 

 

 

 

 

We are looking for high performing individuals and leaders that can take on additional responsibility as they progress in their career. We are committed to providing an environment that fosters career growth and personal development. If you exemplify our values and want to be part of a company that is a global technology leader in the rapidly emerging field of robotic-assisted minimally invasive surgery, this is the role for you.

 

 

 

 

Roles & Responsibilities:

 

 

 

 

• Execute audits with a comprehensive understanding of federal regulatory  requirements and ICH (International Council for Harmonization) guidance on Good Clinical Practice (GCP)
• Work with RAC/ QA Leadership to provide feedback in audits to ensure effective change control that improves overall quality of clinical research programs
• Collaborate with Principal Investigators (PIs), Site monitors, and Research Teams to address audit findings and developing corrective action/preventive action (CAPA) plans.
• Assists with collection and review of regulatory documents within clinical trial master files.
• Conducts data review, query review and data management reviews of clinical research file data
• Working knowledge of electronic systems, eQMS, TMFs and electronic workpapers.
• Execute complex, high profile, and impactful  clinical research, compliance, and continuous improvement initiatives.
• Draft preliminary and final audit reports within a timely manner.
• Assess audit observations, including control weaknesses, with an appropriate degree of professional skepticism, seeking to fully understand risks to the Company.
• Serve as the liaison and subject matter expert between external auditors/inspectors and ISI teams during 3rd party audits and inspections.

 

 

 

 

 

 

 

 

 

Qualifications

Skills, Experience, Education, & Training:

• Minimum  bachelor's degree with 3+ years of clinical study  experience; medical device experience strongly preferred.


• EProven experience of in clinical trials monitoring and  auditing of investigator sites, TMFs, vendors, databases etc


• Direct BIMO (FDA) /CA experience preferred


• Human Subjects Protection Certification, GCP Certification preferred


•  Working knowledge of CFR Title 21 part 812, HIPAA and privacy protection, and human research protection regulations. 


• Proven experience of clinical trial auditing of investigator sites, TMFs, vendors, databases etc


• Professional certification such as (CQA, RAPs, CFE, etc.). preferred


• Excellent written and oral communication skills, with the ability to communicate effectively and professionally across all levels of the organization.


• Strong analytical, organizational, and time management skills.


• Ability to work both independently and/ or in a global team environment.


• High ethical and personal standards. Possess a strong work ethic with a commitment to continuous improvement in a dynamic and changing environment that strives to exceed expectations.

 

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.

 

 

 

 

Additional Information

All your information will be kept confidential according to EEO guidelines.

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 : 25% of the time

Travel Requirements:25% of the time Shift:Day

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