Quality Engineer – Medical Devices

Location

Mahwah, New Jersey, United States

Salary

Not specified

Company

Akash pawar

Job description

### Role & Company / Project Overview An exciting contract opening is available for a Quality Engineer / Quality Assurance Engineer with a leading multinational medical technologies company in Mahwah, New Jersey. In this role, you will provide critical quality engineering support across operations, quality assurance, process control, validation, and continuous improvement initiatives. ### Key Responsibilities & Daily Duties • Formulate and execute First Article Inspection (FAI) strategy, execution, and approvals. • Drive Production Part Approval Process (PPAP). • Manage change controls and conduct comprehensive impact assessments. • Oversee equipment and process validations. • Develop and maintain SOP and Risk Management documentation. • Support continuous quality improvement initiatives and ensure regulatory compliance. ### Required Qualifications, Skills & Experience • Education: Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or a related discipline. • Experience: 2+ years of relevant industry experience. • Medical Device industry experience is highly preferred. • Thorough knowledge of Quality Management Systems (QMS) and Change Management. • Working familiarity with ISO 13485, EU Regulations, GDP, and GMP is highly desirable. • Strong problem-solving, analytical, communication, and documentation skills. • Proven ability to work independently and collaborate effectively across cross-functional and multi-site teams. ### Working Hours, Shifts & Location Details • Location: Onsite at 325 Corporate Drive, Mahwah, New Jersey. • Contract Duration: November 2026 – November 2027. ### Application Instructions Interested candidates or those recommending qualified professionals are encouraged to submit their updated resume for consideration.