Quality Engineer - Medical Devices (ISO & CAPA)

W. L. Gore & Associates; Phoenix (AZ); Hybrid; USD 80,000 - 110,000; Full time

Benefits offered by this job

Associate Stock Ownership Plan

Profit-sharing

Job summary

W. L. Gore & Associates seeks an experienced Quality Engineer in Phoenix to support manufacturing quality and regulatory compliance for implantable device products.

You will help update quality systems, perform product quality determinations, and solve problems with cross-functional teams. The role emphasizes risk-based decision making, CAPA development, and mentorship to ensure product release quality while aligning with ISO 13485 and FDA expectations.

Qualifications

• Bachelor’s degree in engineering or science required with 3+ years hands-on experience.
• Structured problem-solving using 8D, 8‑Step, DMAIC or PDCA with root-cause methods.
• Knowledge of risk management methods and product risk assessment.
• Apply engineering fundamentals and statistics to quality support and troubleshooting.
• Ability to manage multiple projects with teams and timelines.
• Ability to mentor others and work in cross‑functional teams.
• Capable of identifying critical issues and guiding risk‑based decisions.
• Strong documentation and communication of technical work.
• Travel up to 5% must be possible.

Responsibilities

• Ensure ISO and global quality standards for design and performance.
• Update quality system documentation and CAPA planning.
• Support product quality determinations and nonconformance investigations.
• Apply statistics to sampling plans and data-driven decisions.
• Collaborate with manufacturing, QA, and regulatory in product release.
• Maintain Design History Files and risk management tools.
• Provide mentorship and technical support across teams.
• Drive root cause analysis and corrective actions for defects.
• Develop deep product knowledge to support audits and changes.
• Improve processes with cross-functional project participation.

Skills

Structured problem-solving

Statistical analysis

Risk management

Project management

Team collaboration

Education

Bachelor’s Degree in Engineering or Science

Job description

W. L. Gore & Associates seeks an experienced Quality Engineer in Phoenix to support manufacturing quality and regulatory compliance for implantable device products.

You will help update quality systems, perform product quality determinations, and solve problems with cross-functional teams. The role emphasizes risk-based decision making, CAPA development, and mentorship to ensure product release quality while aligning with ISO 13485 and FDA expectations.