Senior Quality Engineer, Medical Devices — Hybrid (NJ)

Intepros; Mahwah (NJ); Hybrid; USD 110,000 - 135,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Quality engineering

Change control

QMS

GDP & GMP

Cross-functional collaboration

Education

Bachelor's degree in Biomedical or Mechanical Engineering

Job description

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.