Date Posted: 10/26/2026
Hiring Organization: Rose International
Position Number: 509803
Industry: Medical Equipment & Supplies
Job Title: Quality Engineer - Medical Device Manufacturing & Quality Systems
Job Location: Mahwah, NJ, USA, 07430
Work Model: Onsite
Shift: 8:00 AM - 5:00 PM, Monday - Friday
Employment Type: Temporary
FT/PT: Full-Time
Estimated Duration (In months): 13
Min Hourly Rate($): 43.00
Max Hourly Rate($): 43.00
Must Have Skills/Attributes: Change Management, Engineering, Quality Assurance, Quality Management
Nice To Have Skills/Attributes: GDP, Medical device, PPAP (Production Part Approval Process)
Experience Desired:
Experience in quality engineering, manufacturing, engineering, or quality assurance (2+ yrs),
Knowledge of Change Management and Quality Management System (QMS) principles (2 yrs),
Experience with medical device industry concepts and quality requirements (0-2 yrs),
Familiarity with ISO 13485, EU regulations, Good Documentation Practices (GDP), and Good Manufacturing Practices (GMP) (0-2 yrs),
Knowledge of First Article Inspection (FAI), Production Part Approval Process (PPAP), equipment and process validation (0-2 yrs)
Required Minimum Education: Bachelor’s Degree
**C2C is not available**
Job Description
Required Education:
• Bachelor’s degree in biomedical engineering, Mechanical Engineering, or a related field
Required Experience:
• Minimum of 2 years of experience in quality engineering, manufacturing, engineering, or quality assurance, preferably in the medical device industry
• Knowledge of Change Management and Quality Management System (QMS) principles
• Understanding of engineering and quality concepts, theories, and procedures
Preferred Experience:
• Experience with medical device industry concepts and quality requirements
• Familiarity with ISO 13485, EU regulations, Good Documentation Practices (GDP), and Good Manufacturing Practices (GMP)
• Knowledge of First Article Inspection (FAI), Production Part Approval Process (PPAP), equipment and process validation, and change control processes
• Understanding of risk-based approaches and statistical concepts
Job Duties:
• Provide quality engineering support for quality assurance, quality control, and preventive activities across operations and other business functions
• Develop and implement methods and procedures for process control, process improvement, testing, and inspection to ensure products meet quality standards and perform as designed
• Develop, execute, and support First Article Inspection (FAI) strategies, including approvals
• Support Production Part Approval Process (PPAP) activities
• Manage change control processes and perform change impact assessments
• Support equipment and process validations
• Update and review Standard Operating Procedures (SOPs) and risk management documentation
• Lead and support initiatives and projects to improve quality performance and ensure compliance with applicable regulations and standards
• Apply sound judgment and professional expertise to resolve quality-related issues independently, with minimal supervision
• Collaborate with cross-functional and multi-site teams to support quality objectives
• Serve as the voice of Quality in cross-functional discussions and decision-making
• Apply analytical and problem-solving skills to identify issues and implement effective solutions
• Maintain accurate documentation and demonstrate strong attention to detail
• Communicate effectively with internal stakeholders and maintain strong working relationships built on trust, respect, and collaboration
• Manage multiple tasks efficiently in a fast-paced environment while maintaining a customer- and stakeholder-focused approach
• Use Microsoft Word, Excel, and PowerPoint to support quality engineering activities and documentation
• Maintain excellent written and verbal communication skills in English
- **Only those lawfully authorized to work in the designated country associated with the position will be considered.**
- **Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client’s business needs and requirements.**
Benefits:
For information and details on employment benefits offered with this position, please visit here. Should you have any questions/concerns, please contact our HR Department via our secure website.
California Pay Equity:
For information and details on pay equity laws in California, please visit the State of California Department of Industrial Relations' website here.
Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.
If you need assistance in completing this application, or during any phase of the application, interview, hiring, or employment process, whether due to a disability or otherwise, please contact our HR Department.
Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.).
Each time I contacted Rose, I was completely satisfied with the great attention and customer service I received. Each person was extremely knowledgeable and patient with my concerns or questions.
Diana, Consultant
My on-boarding with Rose was outstanding. The packets of information, the process, and great attention to detail each person gave me allowed me to get started quickly.I appreciated each person's friendly and helpful attitude.
Diana, Consultant
Any time I did have a question and called, the phone was always answered, and my question/concern was immediately resolved.
Sally, Consultant
Rose is an assembly of people grounded in honesty, truth and dignity for all of its employees and contractors.
Samba, Consultant
The interactions that I have had with your representatives have always been prompt and very professional. I am very pleased and impressed with your company and services.
Sioe, Consultant
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