Description and Requirements
Employment Type: 12-month contract
Work Location: Mahwah, New Jersey
Work Arrangement: Hybrid (3 days onsite)
Hours: 40 hours per week
Pay Rate: $50-52 per hour
Position Summary
As a Quality Engineer, you will provide quality engineering support in quality assurance, control and preventative activities within operations and other business functions. The candidate will be tasked with developing and implementing methods and procedures for process control, process improvement, testing and inspection to ensure that the products are free of flaws and function as designed.
Key Responsibilities
- Product Transfers and Supplier Change Requests
- Production Part Approval Process (PPAP)
- Validation projects for new equipment and processes introduced to the plant.
- First Article Inspection (FAI) strategy development, execution, and approvals.
- Standard Operating Procedures (SOP) and Inspection plan creation and updates through the change management system.
- And more.
Qualification:
- Bachelor’s Degree - Biomedical Engineering, Mechanical Engineering or related field
- 1 + years of experience in industry required
- Knowledge of Change Management and Quality Management Systems (QMS) principles.
- Firm understanding of Med Device concepts highly desirable.
- Familiarity with ISO 13485, GDP, GMP concept highly desirable.
- Excellent communication skills and attention to detail.
- Good understanding of engineering and quality concepts / theories.
- High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
- Self-starter with efficient work style and ability to handle multiple tasks in a fast-paced environment.
- Be willing to work as part of a multi-site team.
- Have knowledge of Risk Based and statistical concepts is desirable.
- Problem solving and analytical skills.
- Be able to build strong relationships by fostering open communications, respect and trust. Strong team player and acts with a customer service/stakeholder focused approach.
- Ability to be the voice of Quality when dealing cross functionally.
- Excellent English (both oral and written).
- Up to 10% travel may be required
The indicated pay range is a good‑faith estimate based on required qualifications, experience, training, and other factors permitted by law. It reflects the pay band established by the client company. Actual offers may vary depending on skills, experience, geographic location, and expected work quality. Most candidates start in the lower half of the range. Pay history is not considered where prohibited by law. This information serves as a general guideline for compensation discussions.
To support a fair and efficient hiring process, we may use artificial intelligence (AI) tools to help review applications. Our team carefully reviews all candidates, and AI is used only as a support tool—never as the sole decision-maker.