Sr. Business Systems Analyst ( eQMS / Veeva/ Trackwise )

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 Sr. Business Systems Analyst, partners with Quality business process owners and SMEs to identify business capability needs, opportunities for efficiency through automation and deliver technology solutions that enhance overall productivity or simplify processes. Ideal candidate has experience advocating technology needs of Quality function with IT and other technical teams, will bring a combination of both business and technology experience, have exceptional relationship building skills, expertise in standing up and sustaining compliant, holistic, and scalable enterprise Quality business systems. This role contributes directly to projects and initiatives by shaping business systems projects, overseeing the implementation, and maintenance of eQMS and other business capability solutions for Quality. This person will be able to understand the current complexities of the organization’s Quality processes and how those processes flow through current technology and help build the future-state to best realize the organization’s growth strategy.

Essential Job Duties

• Partner with Quality Process owners and SMEs to understand business capability needs, deploy technology solutions that meet compliance needs and enhance productivity.
• Collaborate closely with Quality stakeholders to identify and analyze business process issues and opportunities, evaluate potential application of new or modified technology solutions.
• Act as a trusted advisor, translating functional requirements into actionable business system solutions. Advise how technology can improve functional operations and decision-making.
• Bring subject matter expertise to the design and implementation of business system solutions, collaborate cross functionally to discover the root cause of identified issues and develop simple solutions to complex problems.
• Manage projects from initiation to closure ensuring timely delivery.
• Gather, document, and analyze business requirements.
• Coordinate delivery efforts to meet project milestones and goals.
• Facilitate resolution of operational issues ensuring acceptable system testing and timely deployments in collaboration with IT and external vendors to help Quality conduct business more effectively.
• Provide insights to and gain buy-in from key internal stakeholders including but not limited to Regulatory, Product Quality, Manufacturing Operations, Engineering, Supply Chain, and Product Development.
• Partner with IT, Business Applications, IT Support Services and Enterprise Analytics to ensure technology investments align with business capability needs.
• Drive continuous improvement to enhance overall business performance and customer satisfaction by partnering with IT and other global stakeholders, implementing new business system solutions, and supporting future-growth initiatives.
• Create synergies with global business entities to ensure alignment for needs and growth requirements are met.
• Implement and leverage AI and ML technologies to optimize business processes and enhance product capabilities
• Design and implement AI and ML solutions for Quality processes by working with Vendors and/or internal teams.
• Ensure compliance with Quality standards while implementing innovative AI solutions
• Continuously evaluate and improve AI/ML models to enhance Quality operations efficiency
• Nice to have knowledge in programming languages such as JavaScript, Python, or Java
• Experience with applications built on cloud solutions
• Familiarity with web development frameworks and database management systems
• Ensure best practices in code quality, testing, and documentation
• Participate in architectural and design discussions
• Guide customers in adopting industry best practices and change management methodologies

Required Skills and Experience

• 10+ years of overall industry experience with minimum 5+ years of demonstrated expertise implementing or administration of an eQMS or Regulatory or other Quality business systems.
• Preferred experience in implementing eQMS Business systems for Supplier Quality, Product Quality, Field Actions, Non-Conformances, Doc Control. Experience in Complaints, CAPA, and Audits is nice to have.
• Experience working with business software systems, writing product requirements, process mapping, Proven Project Management Experience required. Experience building multi-year improvement roadmaps.
• Excellent verbal and written communication skills, proven ability to translate analytical and technical information into effective presentations for business consumption.
• Ability to comprehend and communicate complex business / technical challenges in a simplified manner.
• Autonomous thinker, willing to present alternative conclusions or inferences.
• Solid attention to detail, organization skills and extensive ability to multi-task and project manage across multiple projects/activities in a team setting.
• Exceptional understanding of SaaS architecture and business models
• Proficiency in programming for data analysis and automation
• Experience with AI and ML technologies and their applications in SaaS environments
• Excellent communication skills to bridge communication between stakeholders
• Experience in small SaaS product companies or startups
• Experience with developing solutions for Quality functions with systems like SAP, Oracle PLM, SFDC, AWS and/or any AI tool kit.
• Knowledge of project management methodologies (e.g., Agile, Scrum)

Required Education and Training

• B.S. or higher in Science, Technology, Engineering, or related field preferred

Working Conditions

• Travel : 10% of the time

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 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.

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.

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 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.

Mandatory Notices

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 compensation ranges are listed.