Quality Engineer – Medical Device

Intepros; New Jersey; Hybrid; USD 55.000 - 83.000; Vollzeit

Zusammenfassung

Intepros in Mahwah, NJ seeks a Quality Engineer to support new product transfer and manufacturing implementation activities. The role will partner with Quality, Design Engineering, Manufacturing Engineering, and suppliers to ensure products and processes meet quality standards and regulatory requirements throughout the transition to production.

This is an initial 12-month assignment with potential for extension or conversion to a permanent position. Hybrid work arrangement: 3 days/week onsite.

Qualifikationen

• Bachelor's degree in Engineering or related technical discipline.
• 1–3 years in Quality or Manufacturing Engineering or related experience.
• Regulated industry experience preferred (medical device/pharma).
• Familiarity with QMS, change control, risk management, and process validation.
• Knowledge of ISO 13485, GMP, GDP or similar standards is a plus.

Aufgaben

• Support quality planning, change control, risk management, and continuous improvement.
• Review equipment qualification, process validation, and FAI documentation.
• Develop and maintain SOPs, quality records, and controlled docs.
• Support root cause investigations and corrective actions.
• Collaborate cross-functionally to ensure compliant processes.
• Track quality deliverables and report project status to stakeholders.

Kenntnisse

Quality planning

Root cause analysis

Documentation

Cross-functional collaboration

Problem solving

Ausbildung

Bachelor's degree in Engineering

Jobbeschreibung

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

Employment Type: Initial 12-month contract, with potential for extension or conversion to a permanent role

Position Overview

A leading medical device manufacturer is seeking a Quality Engineer to support new product transfer and manufacturing implementation activities. This role will partner with Quality, Design Engineering, Manufacturing Engineering, and suppliers to ensure products and processes meet quality standards and regulatory requirements throughout the transition to production.

Key Responsibilities

• Support quality planning, change control, risk management, and continuous improvement activities.
• Review and support equipment qualification, process validation, and First Article Inspection (FAI) documentation.
• Assist with the development and maintenance of SOPs, quality records, and controlled documentation.
• Support root cause investigations, corrective actions, and process improvement initiatives.
• Collaborate cross-functionally to ensure manufacturing processes meet quality and regulatory requirements.
• Track quality deliverables and communicate project status, risks, and issues to stakeholders.

Qualifications

• Bachelor's degree in Engineering or a related technical discipline.
• Approximately 1–3 years of Quality Engineering, Manufacturing Engineering, or related experience; equivalent relevant experience will be considered.
• Medical device, pharmaceutical, or other regulated industry experience preferred.
• Familiarity with quality management systems, change control, risk management, and process validation.
• Knowledge of ISO 13485, GMP, GDP, or similar regulatory standards is a plus.
• Strong analytical, documentation, communication, and problem-solving skills.

This is an initial 12-month assignment with the potential for extension or conversion to a permanent position.