Sr. Quality System Engineer

Sr. Quality System Engineer

It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do  a global leader in robotic-assisted surgery and minimally invasive care, our technologies—like the da Vinci surgical system and Ion—have transformed how care is delivered for millions of patients worldwide.

We're a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.

The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement we make has the potential to change a life.

If you're ready to contribute to something bigger than yourself and help transform the future of healthcare, you'll find your purpose here.

Senior professional individual contributor leading complex QMS compliance initiatives, policy implementation, risk assessments, remediation actions, audit readiness, and cross-functional quality system projects. Provides technical leadership and supports alignment across functions, sites, regions, and business units.

Essential Job Duties

• Lead complex QMS compliance projects, risk assessments, remediation plans, policy implementation, and quality plan execution across functions or sites.
• Define implementation approach, deliverables, governance, risks, success criteria, and escalation pathways.
• Provide senior-level review of QMS changes, procedures, training plans, records, dashboards, and implementation evidence.
• Lead cross-functional meetings, align stakeholders, remove barriers, and drive action closure.
• Mentor junior specialists and provide technical guidance on QMS compliance execution.
• Support regulatory inspections, notified body audits, industry reviews, client reviews, and executive updates.
• Drive process standardization, compliance technology adoption, digital workflow improvements, and continuous improvement.

Required Skills and Experience

• 6 to 10 years of experience in Quality Systems, Compliance, Regulatory, Engineering, Operations, or a related field.
• Strong knowledge of medical device QMS requirements and regulated change implementation.
• Experience leading cross-functional QMS projects, policy implementation, risk assessments, remediation activities, audit readiness, or inspection support.
• Strong technical writing, risk-based thinking, stakeholder management, executive communication, and project leadership skills.
• Ability to coach junior team members and influence cross-functional teams without direct authority.
• Ability to translate regulatory and procedural requirements into practical implementation plans.

Required Education and Training

• Bachelor's degree in engineering, Life Sciences, Quality, Regulatory Affairs, Compliance, or related discipline.
• Equivalent combination of education and relevant experience may be considered.
• Advanced degree or professional certification preferred.
• Training in medical device QMS requirements, quality planning, audit support, risk management, project leadership, remediation management, and Good Documentation Practices required.

Working Conditions

• Office or hybrid work environment.
• Frequent cross-functional engagement across sites, regions, business units, and process ownership teams.
• Work may include time-sensitive deliverables, audit readiness support, inspection response, remediation tracking, and leadership reporting.
• Requires the ability to manage multiple priorities and support business needs across time zones.
• Domestic or international travel may be required to support inspections, projects, site readiness, or implementation.

Preferred Skills and Experience

• Experience leading quality plans, QMS remediation, policy implementation, regulatory inspection readiness, process standardization, compliance technology implementation, or multi-site QMS deployment.
• Certifications such as ASQ CQA, CQE, CMQ/OE, RAC, Lean Six Sigma, or PMP preferred.
• Experience mentoring junior staff and…