Staff (Quality Engineer 5) - New Product Development

Intuitive; Sunnyvale (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Intuitive in Sunnyvale, CA seeks a Staff Quality Engineer to drive enterprise quality initiatives, shape quality practices, and act as a technical and leadership authority across business units.

You will own design controls, risk management, CAPAs, investigations, and audits; mentor engineers; ensure GMP, ISO, and FDA compliance; and advise cross-functional teams on quality requirements to sustain product excellence.

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.
• Indentification, 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.
• Indentification 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
• o Advocate product design history file and ensure compliance with internal processes and external standards and regulations.
• o Understand user needs and assure they are translated to the design, while ensuring compliance with usability and human factors standards and regulations.
• o Partner with engineering to define design inputs, design outputs, and traceability matrices.
• o Contribute to the strategy and execution of risk-based design verification and validation.
• o 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
• o Review and provide feedback on design architecture, selections, requirements, and drawings from early design.
• o Collaborate with manufacturing, purchasing, test engineering, and supplier engineering to facilitate transfer of scalable designs into production.
• 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

Job description

Job Description

Primary Function of 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.

Essential Job Duties

• 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.
• Indentification, 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.
• Indentification 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
• o Advocate product design history file and ensure compliance with internal processes and external standards and regulations.
• o Understand user needs and assure they are translated to the design, while ensuring compliance with usability and human factors standards and regulations.
• o Partner with engineering to define design inputs, design outputs, and traceability matrices.
• o Contribute to the strategy and execution of risk-based design verification and validation.
• o 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
• o Review and provide feedback on design architecture, selections, requirements, and drawings from early design.
• o Collaborate with manufacturing, purchasing, test engineering, and supplier engineering to facilitate transfer of scalable designs into production.

Breadth of Impact and Leadership

• 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