Sr. Quality System Engineer
Intuitive•Sunnyvale, CA
•$126,800 - $214,800•Onsite
About The Position
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.
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.
Benefits
- Market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
