Senior Quality Systems Engineer

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:

This position involves coordinating regulatory compliance activities, understanding and mitigating potential non-compliance risks, and participating in strategic planning meetings to ensure compliance with global regulatory requirements as well as company policies. This role is responsible for interpreting relevant regulations and implementing practical compliance solutions.

Essential Job Duties:

• Develop and implement comprehensive compliance programs and policies
• Conduct regular audits and assessments to ensure adherence to regulatory requirements and internal controls
• Maintain compliance with global regulatory requirements
• Proactively identify and strategize ways to mitigate risks of non-compliance
• Maintain accurate records of compliance activities and findings
• Understand and provide guidance and training to employees on compliance related matters
• Investigate and resolve compliance-related issues, including potential violations
• Stay informed about industry best practices and emerging compliance trends.
• Prepare and submit reports on compliance activities
• Collaborate with cross functional teams to integration compliance requirements in other processes
• Other duties as required.

Qualifications

Required Skills and Experience:

• Minimum 10 years in a quality, compliance, or regulatory role in the medical device or other regulated manufacturing environment
• At least 5 years of experience managing/leading QMS for a Class III devices
• At least 5 years of experience working with Clinical, Regulatory, and Organizations on compiling and reviewing PMAs
• Experience hosting and leading PAI (Pre-Approval Inspection) for PMA
• Responsible to work in office at least 80% of the time.
• Experience as an FDA inspector is a Plus.
• Experience with Technology medical devices products such as robotics, software, mechanical, and electrical is a Plus.
• Ability to understand applicable industry regulations
• Working knowledge of implementing and providing guidance on domestic and international regulations
• Proven organizational, written and verbal communication skills

Required Education and Training:

• Minimum Bachelor's degree in relevant field

Preferred Skills and Experience:

• Experience conducting research, analyzing information and data, and presenting findings in a clear and concise format
• Knowledge of applicable laws, regulations, and statutes related to employment, benefits, and HR compliance globally
• Experience designing and administering scalable compliance-related processes and programs
• Experience working directly with agencies like FDA, Notified Bodies, or others, as applicable
• Knowledge of validation methodologies pertaining to computer system, process, and equipment preferred
• Six Sigma Greenbelt certification or other professional certification (e.g., ASQ certification)
• Solid judgment abilities and skills
• Ability to engage in constructive dialogue

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 curr