Quality Assurance Engineer

Job Title: Quality Assurance Engineer

Location: Mahwah, NJ

Type: Contract

Compensation: $42 - $48/hr

Work Model: Hybrid – onsite and remote

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 products are flaw-free and function as designed.
• Support Product Transfers and Supplier Change Requests.
• Assist with Production Part Approval Process (PPAP).
• Participate in validation projects for new equipment and processes introduced to the plant.
• Contribute to First Article Inspection (FAI) strategy development, execution, and approvals.
• Create and update Standard Operation Procedures (SOP) and Inspection plans through the change management system.
• Advocate and lead initiatives and projects to enhance quality performance and ensure compliance to 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 Med Device concepts.
• Familiarity with ISO 13485, GDP, GMP concepts.
• Excellent communication skills and attention to detail.
• Good understanding of engineering and quality concepts / theories.
• 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.
• 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