Staff Quality Engineer

Intuitive•Sunnyvale, CA

8d•Onsite

About The Position

This role drives enterprise level quality outcomes by leading strategic initiatives, shaping quality practices, and influencing decisions across business units. The Staff QE operates with broad autonomy and is recognized as a technical and leadership authority.

Requirements

Minimum 12 years of experience in QE/QA and bachelor’s degree in engineering or relevant discipline, or equivalent combination of education and experience
Advanced understanding of quality principles and methodologies
Advanced data analysis and data interpretation skills
Expert ability to resolve quality issues
Respected ability to foster a quality culture
Expert communication and team collaboration, ability to influence stakeholders, executive presence
Expertise with evolving quality standards, tools and technologies
Strong ability to mentor and teach junior engineers

Nice To Haves

Demonstrated impact at BU or enterprise level
Outcomes are adopted and sustained beyond the business unit
Develops other Senior QEs into future Staff level leaders
Influences senior leadership decisions through data, judgment, and presence
Acts as a role model for quality culture and leadership behaviors

Responsibilities

Leads initiatives that change how quality is executed across multiples BUs or sites
Establishes standards, frameworks, or methodologies adopted beyond local teams
Serves as escalation owner for high impact product quality & compliance risks
Leadership of critical product, process investigations and audits.
Indenification, execution and advise on strategic quality projects with company wide impact.
Ownership of quality investigations for complaints and non-conformances.
Author, review, and approve QA documentation, protocols
Leadership of critical CAPAs
Serves as subject matter expert in critical audits.
Analyze and interpret advanced quality data and KPI trends.
Mentor junior and senior engineers in technical expertise.
Ensure compliance with company and regulatory standards (GMP, ISO, FDA). Provides industry expertise.
Advise cross-functional teams on quality requirements.
Indenification and ownership of continuous improvement projects.
Design Control and Risk Management Stewardship: Planning and execution of design controls, risk management, and design verification/validation for new products
Advocate product design history file and ensure compliance with internal processes and external standards and regulations.
Understand user needs and assure they are translated to the design, while ensuring compliance with usability and human factors standards and regulations.
Partner with engineering to define design inputs, design outputs, and traceability matrices.
Contribute to the strategy and execution of risk-based design verification and validation.
Accountable for overall risk management file: participate and support the development of product risk management file, to analyze and assess the product risks associated with user, design, process and supplier.
Support design controls activities associated with new product development. Advocate and ensure the transfer of reliable and scalable designs to manufacturing
Review and provide feedback on design architecture, selections, requirements, and drawings from early design.
Collaborate with manufacturing, purchasing, test engineering, and supplier engineering to facilitate transfer of scalable designs into production.