Quality Engineer I

Role Overview

We are seeking an experienced Quality Engineer I to develop and maintain quality engineering methodologies and provide quality engineering support within new product development, manufacturing, or system/services support. This role is responsible for implementing process control systems, leading quality initiatives, and resolving quality issues.

What You Will Do

Identify and implement effective process control systems, lead in the implementation of assurances and process controls, assist in the development of streamlined business systems, and apply sound problem-solving methodologies to identify and resolve quality issues.

Why It Might Be a Fit

This role requires a strong background in quality engineering, experience with FDA regulations, and knowledge of quality tools and methodologies. The ideal candidate will have excellent communication and interpersonal skills, project management and leadership skills, and the ability to work in a fast-paced, changing environment.

Requirements

• BS degree in Engineering or Technical Field
• Minimum 2 years of Engineering experience
• Demonstrated use of Quality tools/methodologies
• Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971
• Solid communication and interpersonal skills
• Project management and leadership skills
• Advanced computer skills, including statistical/data analysis and report writing skills

Benefits

• Training and career development
• Financial security through competitive compensation, incentives and retirement plans
• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
• Paid time off
• 401(k) retirement savings with a generous company match