Quality Engineer

Intepros; Mahwah (NJ); Hybrid; USD 110.000 - 135.000; Vollzeit

Zusammenfassung

Intepros is seeking a Senior Quality Engineer for a 12-month contract in Mahwah, NJ, with hybrid work (3 days/week). The role focuses on supporting a new product transfer, process validation, and quality planning across Design, Manufacturing, and Project teams.

The ideal candidate brings 4+ years in quality or manufacturing engineering, strong experience with validation activities, and solid knowledge of ISO 13485, GDP, and GMP practices to ensure compliant, production-ready systems.

Qualifikationen

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or a related field.
• 4+ years of Quality/Manufacturing engineering experience.
• 2+ years of equipment/process validation experience.
• Familiarity with ISO 13485, EU medical device regulations, GDP, and GMP.

Aufgaben

• Develop, execute, review, and approve FAI strategies and documentation.
• Lead change control activities, including technical reviews and impact assessments.
• Support equipment and process validation activities with validation protocol owners.
• Develop, review, and execute validation documentation and ensure quality requirements are addressed.
• Review and update SOPs and quality records with document owners.
• Coordinate with cross-functional teams to communicate progress and risks.
• Collaborate with Design and Manufacturing Engineering to integrate Quality requirements into plans.
• Engage suppliers to support project and quality requirements.
• Identify opportunities to improve product and process quality while ensuring regulatory compliance.
• Manage multiple quality deliverables and timelines to meet project milestones.

Kenntnisse

Quality engineering

Change control

QMS

GDP & GMP

Cross-functional collaboration

Ausbildung

Bachelor's degree in Biomedical or Mechanical Engineering

Jobbeschreibung

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).