Quality Engineer

Senior Quality Engineer - Medical Device

Location: Mahwah, NJ | Hybrid, 3 days/week

Employment Type: 12-Month Contract

Position Overview

A leading medical device manufacturer is seeking an experienced Senior Quality Engineer to support a new product transfer and manufacturing implementation project. This individual will serve as a key Quality representative, partnering closely with Design Engineering, Manufacturing Engineering, Project Management, suppliers, and other cross-functional stakeholders to ensure products and processes are compliant, controlled, validated, and ready for production. The Senior Quality Engineer will support quality planning, process control, validation, inspection, risk management, and change control activities throughout the project lifecycle.

Key Responsibilities

• Develop, execute, review, and approve First Article Inspection (FAI) strategies and documentation.
• Lead and support change control activities, including technical reviews and change impact assessments.
• Review and support equipment and process validation activities in collaboration with validation protocol owners.
• Support the development, review, and execution of validation documentation and ensure appropriate quality requirements are addressed.
• Review and update SOPs, risk management documentation, and quality records in partnership with document owners.
• Participate in cross-functional project meetings and communicate progress, risks, and status of Quality deliverables.
• Partner with Design Engineering, Manufacturing Engineering, and Project Management to establish project strategy and ensure Quality requirements are incorporated into project plans.
• Collaborate with equipment, component, and material suppliers as needed to support project and quality requirements.
• Identify and lead opportunities to improve product and process quality while maintaining compliance with applicable regulations, standards, and Quality Management System requirements.
• Manage multiple quality deliverables and priorities while ensuring project timelines are met.

Qualifications

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or a related engineering discipline.
• 4+ years of Quality Engineering, Manufacturing Engineering, or related industry experience.
• 2+ years of experience supporting equipment and/or process validation.
• Working knowledge of change control/change management and Quality Management System (QMS) principles.
• Medical device industry experience preferred
• Familiarity with ISO 13485, applicable EU medical device regulations, Good Documentation Practices (GDP), and Good Manufacturing Practices (GMP).