Engineer, Quality Assurance - Hybrid

Overview

Engineer, Quality Assurance – Hybrid role located in Mahwah, New Jersey. Hybrid schedule with a minimum of 3 days on site.

Start date:

8/3/2026;
End date: 8/2/2027. Pay rate: $37.22/hr shift:
First Shift, 8:00 AM – 5:00 PM.

Location:

Mahwah, NJ.

• Provide quality engineering support in quality assurance, control and preventative activities within operations and other business functions.
• Develop and implement methods and procedures for process control, process improvement, testing and inspection to ensure products are free of flaws and function as designed.
• Support validation projects for new equipment and processes introduced to the plant.
• Develop, execute, and obtain approvals for First Article Inspection (FAI) strategies.
• Create and update Standard Operating Procedures (SOP) and Inspection plans through the change management system.
• Collaborate with Manufacturing Engineering, Sterility Assurance, and Design Teams to land new equipment and set up the process for quality and compliance success by implementing appropriate risk-based process controls and equipment maintenance measures.
• Advocate and lead initiatives and projects to enhance quality performance and ensure compliance with regulations and standards.

• 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) principles.
• Firm understanding of Medical Device concepts is highly desirable.
• Familiarity with ISO 13485, GDP, GMP concepts is highly desirable.
• Excellent communication skills and attention to detail.
• Strong understanding of engineering and quality concepts/theories.
• High level of PC skills; proficient with Microsoft Word, Excel and PowerPoint.
• Self-starter with efficient work style and ability to handle multiple tasks in a fast-paced environment.
• Willing to work as part of a multi-site team.
• Knowledge of risk-based and statistical concepts is desirable.
• Strong problem-solving and analytical skills; ability to build strong cross-functional relationships and maintain a customer service/stakeholder-focused approach.
• Ability to be the voice of Quality when dealing cross-functionally.
• Excellent English (oral and written).

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