Quality Engineer, Medical Devices – Hybrid Role

wlgore; Phoenix (AZ); Hybrid; USD 85,000 - 105,000; Full time

Job summary

Gore seeks an experienced Quality Engineer in Phoenix, Arizona, to support the manufacturing of implantable devices and maintain ISO compliance. You will update quality system documentation, perform product quality determinations, and work with cross-functional teams to ensure regulatory and quality standards are met.

Responsibilities include CAPA, design history file ownership, and collaboration with QA, Manufacturing, and Regulatory to drive root-cause analyses and continuous improvement.

Qualifications

• Bachelor’s degree in engineering or science with minimum 3 years of hands-on engineering experience.

Responsibilities

• Ensure continued compliance to ISO and global quality standards/guidelines for product design and performance; address documentation gaps and updates (FMEAs, ERT, PERC).
• Identify and address opportunities to improve manufacturing processes and assess regulatory, quality, ergonomic, safety, environmental, and cost impact.
• Employ statistical techniques to promote data-driven decisions; establish sampling plans and troubleshoot for continuous improvement.
• Partner with engineers across development cycles: scale-up, validation, and improvement.
• Provide support and mentorship using engineering principles to ensure quality decisions for product release and supplier quality.
• Provide technical support for manufacturing Gore PRECLUDE Pericardial Membrane and GORE-TEX Cardiovascular Patch; collaborate with QA, Manufacturing, Regulatory.
• Apply formal problem-solving to determine root cause in CAPA and implement corrective actions.
• Own design control deliverables and maintain Design History Files (input/output docs, risk tools).
• Develop deep technical knowledge of product documentation to support audits and change control.

Skills

Structured problem-solving

Root cause analysis

Statistical analysis

Project management

Cross-functional collaboration

Documentation and communication

Travel up to 5%

Education

Bachelor’s Degree in Engineering or Science

Job description

Gore seeks an experienced Quality Engineer in Phoenix, Arizona, to support the manufacturing of implantable devices and maintain ISO compliance. You will update quality system documentation, perform product quality determinations, and work with cross-functional teams to ensure regulatory and quality standards are met.

Responsibilities include CAPA, design history file ownership, and collaboration with QA, Manufacturing, and Regulatory to drive root-cause analyses and continuous improvement.