Quality Engineer

Role Overview

As a Quality Engineer, you will provide quality engineering support across quality assurance, control, and preventative activities within operations and other business functions. You'll develop and implement methods and procedures for process control, process improvement, testing, and inspection to ensure products meet design and quality standards.

Location:

Mahwah, NJ (minimum 3 days on-site)

• Validation projects for new equipment and processes introduced to the plant
• First Article Inspection (FAI) strategy development, execution, and approvals
• Standard Operating Procedure (SOP) and inspection plan creation/updates through change management

You will collaborate with Manufacturing Engineering, Sterility Assurance, and Design teams to implement risk-based process controls and equipment maintenance measures for new equipment.

This is an individual contributor role requiring independent judgment and professional expertise, typically suited to someone with a university degree or equivalent practical experience.

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or related field
• 1+ years of industry experience
• Knowledge of Change Management and Quality Management Systems (QMS)
• Strong problem-solving and critical thinking skills
• Ability to independently apply engineering rationale to decisions
• Experience with validation processes
• Excellent communication skills (oral and written) and attention to detail
• Proficiency in Microsoft Word, Excel, and Power Point

• Understanding of medical device concepts, ISO 13485, GDP, and GMP
• Experience developing or approving SOPs
• Familiarity with risk-based and statistical concepts
• Self-starter, comfortable in a fast-paced, multi-site team environment

Not typically required; occasional travel possible (up to 10%)