Quality Engineer - Med Device | Process Excellence & CAPA

The Fountain Group; San Diego (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

The Fountain Group is seeking a Quality Engineer to develop and maintain quality engineering methodologies and provide support across new product development, manufacturing, or service areas. The role emphasizes process control, CAPA, risk analysis, and cross‑functional leadership.

Responsibilities include leading investigations, applying Six Sigma/Lean practices, and collaborating with design engineers on verification and validation activities within a medical device context.

Qualifications

• Bachelor’s or Master’s degree in Engineering with at least 2 years of quality experience.
• Experience in medical device industry with FDA, GMP, ISO 13485 and ISO 14971 knowledge.
• Strong project management and cross‑functional leadership abilities.
• Advanced computer skills including statistical analysis and report writing.
• Experience implementing Six Sigma and Lean Manufacturing.
• ASQ CQE or similar certification is a plus.

Responsibilities

• Identify and implement effective process control systems to support development, qualification, and ongoing manufacturing.
• Lead in the implementation of assurances, process controls, and CAPA systems.
• Assist in developing streamlined business systems to identify and resolve quality issues.
• Apply systematic problem‑solving to identify, prioritize, communicate, and resolve quality issues.
• Design and conduct experiments for process optimization and improvement.
• Document experiment plans and results, including protocol writing and reports.
• Lead process control and monitoring of CTQ parameters and specifications.
• Lead and implement Six Sigma and Lean Manufacturing methodologies.
• Lead investigations and prevention of product and process non‑conformances.
• Participate in or lead teams supporting quality disciplines and practices.
• Lead in completion and maintenance of risk analysis.
• Collaborate with design engineering on product verification and validation.

Skills

Quality tools

Statistical analysis

Report writing

Project management

Leadership

Six Sigma

Lean Manufacturing

CQE certification

Education

Bachelor’s or Master’s degree in Engineering

Tools

Statistical software

Quality management tools

Job description

The Fountain Group is seeking a Quality Engineer to develop and maintain quality engineering methodologies and provide support across new product development, manufacturing, or service areas. The role emphasizes process control, CAPA, risk analysis, and cross‑functional leadership.

Responsibilities include leading investigations, applying Six Sigma/Lean practices, and collaborating with design engineers on verification and validation activities within a medical device context.