Staff Quality System Engineer

Intuitive•Sunnyvale, CA

7d•Hybrid

About The Position

This is a Principal-level professional individual contributor role focused on leading enterprise-wide or global compliance initiatives. The role involves driving policy development, major risk assessments, remediation projects, compliance strategy, audit response, training programs, technology adoption, and business integration activities. The position requires representing the organization in regulatory, client, industry, or executive interactions.

Requirements

Minimum 12 years of compliance, quality systems, or regulatory program experience, or equivalent combination of education and experience.
Deep expertise in global or regional regulations and quality system requirements relevant to the business.
Demonstrated experience leading enterprise or global compliance programs, major risk assessments, remediation projects, audit responses, investigations, and cross-functional initiatives.
Mastery in strategic planning, policy writing, enterprise risk management, audit management, and regulatory interface activities.
Strong executive communication, training, talent development, change leadership, and program management capabilities.
Ability to influence senior leaders and represent the company in regulatory, client, or industry interactions.
Bachelor’s degree in a relevant field, or equivalent combination of education and experience.

Nice To Haves

Advanced degree preferred.
Training or certification in quality systems, auditing, enterprise risk management, regulatory compliance, project management, change leadership, or compliance program management preferred.
Experience leading enterprise QMS programs, global compliance harmonization, regulatory remediation, Class II or Class III medical device compliance, IVD or IVDR, post-merger integration, digital compliance transformation, regulatory agency interactions, and executive governance forums.
Advanced certifications such as ASQ CQA, CQE, CMQ/OE, RAC, Lean Six Sigma Black Belt, PMP, or enterprise risk management certification preferred.
Experience influencing executive leadership and representing the company externally preferred.

Responsibilities

Develop, implement, and harmonize compliance programs, policies, and QMS controls company-wide or globally.
Lead major risk assessments, gap assessments, company investigations, remediation projects, and CAPA-related compliance programs.
Guide responses to high-profile regulatory audits, inspections, client reviews, and industry assessments.
Advise executives on compliance risks, regulatory trends, business impact, and company strategy.
Lead compliance training initiatives and develop core certification programs.
Mentor and coach senior compliance specialists.
Oversee compliance technology adoption and digital transformation.
Align compliance operations with business performance and industry benchmarks.
Represent the organization at external forums, industry events, and regulatory agencies.
Lead post-merger, expansion, and business integration compliance due diligence.