Sr Quality Engineer.

Senior Quality Engineer supporting quality assurance operations in a regulated medical device manufacturing environment. The role involves investigations, nonconformance management, process validation, and cross-functional collaboration to maintain FDA and ISO compliance while driving continuous improvement.

Responsibilities

• Develop, modify, and maintain quality standards and protocols for material processing
• Support investigations, nonconformance management, CAPA, change control, and validation activities
• Devise and implement inspection, testing, and evaluation methods for products and equipment
• Partner cross-functionally with manufacturing, engineering, and operations teams on quality issues
• Conduct statistical analysis and ensure corrective measures meet reliability standards

Requirements

• Bachelor's degree in engineering required
• Minimum 4 years relevant engineering, quality, or manufacturing experience
• Strong technical problem-solving and quality systems knowledge
• Experience with FDA, ISO, GMP regulations and compliance documentation
• Practical knowledge of nonconformance management, CAPA, and change control
• Manufacturing process experience and statistical analysis capability