Staff Quality Engineer - New Product Development

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.

 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.

 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.

 Indentification and ownership of continuous improvement projects.

 Design Control and Risk Management Stewardship: Planning and execution of design controls, risk management, and

o Advocate product design history file and ensure compliance with internal processes and external standards and

o Understand user needs and assure they are translated to the design, while ensuring compliance with usability

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

o Review and provide feedback on design architecture, selections, requirements, and drawings from early

o Collaborate with manufacturing, purchasing, test engineering, and supplier engineering to facilitate transfer of

 Outcomes are adopted and sustained beyond the business unit

 Influences senior leadership decisions through data, judgment, and presence

 Acts as a role model for quality culture and leadership behaviors

 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

 Expert communication and team collaboration, ability to influence stakeholders, executive presence

 Expertise with evolving quality standards, tools and technologies

 Occasional lifting (<25 lbs) and PPE for production or regulated areas.

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.

Required Experience and Education

 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

 Expert communication and team collaboration, ability to influence stakeholders, executive presence

 Expertise with evolving quality standards, tools and technologies

 Occasional lifting (<25 lbs) and PPE for production or regulated areas. 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.

 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.

 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.

 Indentification and ownership of continuous improvement projects.

 Design Control and Risk Management Stewardship: Planning and execution of design controls, risk management, and

o Advocate product design history file and ensure compliance with internal processes and external standards and

o Understand user needs and assure they are translated to the design, while ensuring compliance with usability

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

o Review and provide feedback on design architecture, selections, requirements, and drawings from early

o Collaborate with manufacturing, purchasing, test engineering, and supplier engineering to facilitate transfer of

 Outcomes are adopted and sustained beyond the business unit

 Influences senior leadership decisions through data, judgment, and presence

 Acts as a role model for quality culture and leadership behaviors