About the Role

We are looking for a Quality Engineering Leader to join our team in Aortic.  In this role, you will lead and mentor a team of Quality Engineers to ensure Subject Matter Expertise exists within the business for key Quality Engineering disciplines such as Design Control, Risk Management, Requirements Development, Verification & Validation, and Usability.  You will organize and support the team to deliver on quality engineering needs for new product development (NPD) work, while ensuring all quality engineering activities meet the highest standards and align with our quality system and external standards.  Additionally, you will create and implement development strategies to drive excellence and advance team skills, fostering a culture of quality, innovation, and inclusivity.  This position offers the opportunity to significantly impact on the quality and safety of our medical devices, promoting professional growth and continuous improvement within the business. 

This position will be located at our facility in Phoenix or Flagstaff, Arizona, with the possibility of a hybrid work arrangement.

Responsibilities

• Lead, develop, and manage performance of a team of quality engineers to effectively execute on design control, risk management, requirements development, test method development, verification & validation, usability, sampling plans, and design history file creation & maintenance
• Serve as the subject matter expert and technical representative for the quality engineering function, leading and directing work on multiple projects in a fast-paced, cross-functional environment
• Drive the forecast, strategy, hiring, and alignment of your team to deliver on the quality engineering needs of NPD projects and GBS-related improvements from early-stage development through commercialization
• Create and implement a development strategy to drive engineering excellence and advance the skills, knowledge, and contributions of a team of quality engineers, fostering growth opportunities for all levels of quality engineers
• Develop a group of subject matter experts that are knowledgeable about relevant standards and regulatory requirements and can support audits for their projects and the processes that enable them
• Work collaboratively with business, project, and functional leadership, ensuring timely and effective communication and resolution of quality engineering needs or issues
• Collaborate with other Quality Engineering Leaders within Gore Medical to harmonize and deliver on quality engineering best practices
• Foster a culture of quality, innovation, and community within the business’s quality engineering team, championing a culture of high associate engagement
• Identify, propose, and drive continuous improvements to the NPD process, quality system processes, and tools that support Gore Medical R&D goals and align quality engineers to assist with this continuous improvement work
• Establish clear expectations of equitable and inclusive behaviors from Associates and act immediately to appropriately address negatively impactful or unfair behavior

Required Qualifications

• Bachelor’s degree in engineering or science (biomedical, mechanical, chemical, materials, electrical, or a related field) with a minimum of 6 years of experience in medical device new product development
• Proven track record of leading, developing, and motivating a team of engineers, fostering a culture of quality, innovation, and community
• Experience in creating and maintaining an inclusive work environment with clear understanding of equitable practices
• Experience in executing and navigating quality engineering disciplines, such as design control, risk management, requirements development, and verification & validation
• Experience in project management, including the ability to create an accurate forecast, prioritize tasks, align the right resources to work at the right time, and manage multiple projects simultaneously
• Proven track record of collaborating with and achieving business objectives on a cross-functional team
• Strong communication skills for interacting with and influencing engineers, leaders, and stakeholders
• Strong problem-solving and decision-making skills in complex, ambiguous situations and for challenging issues
• Ability to update and maintain internal processes related to engineering disciplines based on regulations, industry best practices, and business needs
• Ability to travel up to 20%

Desired Qualifications

• Experience leading the performance and development of a team of quality engineers executing new product development activities.
• Experience in quality engineering disciplines, such as test method development, sampling plans, and usability.
• Ability to know when to apply statistical analyses and how to drive effective data driven decision making

This position offers a hybrid work arrangement in the country from which the Associate is employed. Eligibility is dependent on the responsibilities of the role and business needs, and the Associate must agree to comply with Gore’s work arrangement policies.