Quality Engineer

About the Role

We are looking for a Quality Engineer to join our team. In this role, you will be part of an engineering team supporting the stability program for coated medical devices. You will be working closely with manufacturing, chemical processing, quality control inspection, lab areas, and regulatory associates; along with partnering with upstream and downstream supply chain partners to execute stability studies. You will be coordinating device gathering, coating, storing, retrieving, testing, and reporting on test results for different test timepoints within stability studies.

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

Responsibilities

• Partner with upstream supply chain partners to schedule and receive stability study devices.
• Coordinate the movement of stability study devices through the coating process, move them into storage, and retrieve selected timepoints for testing.
• Document and communicate stability study results per quality system requirements for regulatory compliance.
• Apply project management tools and practices to schedule and manage studies to meet critical timelines.
• Collaborate across cross-functional supply chain teams to plan and manage stability studies to meet regulatory requirements.
• Collaborate with other stability engineers and technicians to plan and manage stability studies for multiple commercial product lines, new product development, and other required changes.
• Utilize lifecycle management software to control documentation and approve changes

Required Qualifications

• Bachelor's degree in Engineering or Science
• Minimum of 2 years working experience in a science related field
• Experience working in a manufacturing environment, preferably in a regulated medical device organization
• Experience originating quality system objects (COs, NCRs, SMRs)
• Ability to understand and apply engineering fundamentals or scientific methodologies
• Demonstrated ability to collect data, statistically analyze the results, and provide data supported decisions
• Demonstrated technical writing capability
• Self motivated and able to prioritize multiple projects to meet critical timelines
• Ability to work effectively in team situations while building an inclusive environment, as well as the ability to independently prioritize, initiate, and drive projects to completion
• Ability to travel up to 5%

Desired Qualifications

• Prior experience with coated medical devices
• Experience working within quality systems; quality and technical documentation authoring and review
• Experience with medical device or pharmaceutical regulations, submissions, or working with regulatory bodies

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.