Quality Assurance Engineer

Job Title: Quality Assurance Engineer

Location: Mahwah, NJ

Type: Contract

Compensation: $32 - $37/hr

Work Model: Hybrid – onsite and remote

Overview
Advance your quality engineering career with a global medical technology leader known for its collaborative culture, innovation, and commitment to improving patient care. In this hybrid contract role, you'll partner with cross-functional teams to support process improvements, equipment validation, and quality initiatives while helping ensure products meet the highest regulatory and performance standards.

Responsibilities
• 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 product quality and functionality
• Support validation projects for new equipment and processes introduced to the plant
• Develop, execute, and approve First Article Inspection (FAI) strategies
• Create and update Standard Operating Procedures (SOP) and Inspection plans through change management systems
• Collaborate with Manufacturing Engineering, Sterility Assurance, and Design Teams to ensure quality and compliance success through risk-based process controls and equipment maintenance measures
• Advocate and lead initiatives/projects to enhance quality performance and ensure compliance with regulations and standards
• Work independently with minimal supervision utilizing professional judgment and expertise

Requirements
• 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
• Familiarity with ISO 13485, GDP, GMP concepts highly desirable
• Excellent communication skills and attention to detail
• Strong understanding of engineering and quality concepts/theories
• Proficient in Microsoft Word, Excel, and PowerPoint
• Self-starter with efficient work style capable of handling multiple tasks in a fast-paced environment
• Willingness 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 foster open communication, respect, and trust as a strong team player
• Excellent English (oral and written) skills
• Up to 10% travel may be required

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Ref: #558-Scientific