Sr. Quality System Engineer

Intuitive•Sunnyvale, CA

4d•Hybrid

About The Position

This is a primary function of a Senior professional individual contributor role. This role leads complex QMS compliance initiatives, policy implementation, risk assessments, remediation actions, audit readiness, and cross-functional quality system projects. The role provides technical leadership and supports alignment across functions, sites, regions, and business units.

Requirements

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

Nice To Haves

Advanced degree or professional certification preferred.
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 preparing executive-level compliance updates preferred.

Responsibilities

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.