Senior Quality Engineer – EU-MDR Compliance (Onsite)

Intepros; Mahwah (NJ); On-site; USD 110,000 - 140,000; Full time

Job summary

Intepros in Mahwah, NJ is searching for a Senior Quality Engineer to support EU-MDR compliance initiatives and ensure products and manufacturing processes meet rigorous regulatory standards.

The role leads FAI and PPAP activities, manages change controls, validates equipment and processes, and collaborates with cross-site teams to drive quality improvements and maintain QMS compliance.

Qualifications

• Bachelor's degree in Biomedical or Mechanical Engineering required.
• 4+ years of experience in quality engineering.
• 2+ years supporting EU-MDR programs or regulatory compliance initiatives.
• Strong change control and QMS knowledge.
• Excellent communication and problem-solving skills.

Responsibilities

• Lead First Article Inspection (FAI) activities with strategy, execution, documentation and approvals.
• Support PPAP activities to ensure product and process quality requirements are met.
• Manage change control processes and assess impact on product quality and regulatory compliance.
• Review and update SOPs, risk management documentation, and quality records.
• Support equipment and process validation to ensure compliance with quality standards.
• Identify opportunities for continuous improvement and implement solutions to enhance product quality and manufacturing processes.
• Ensure compliance with regulatory requirements, quality management systems, and internal procedures.
• Collaborate with cross-functional and multi-site teams to resolve quality issues and support regulatory initiatives.

Skills

Quality engineering

Regulatory compliance

Change control

Analytical thinking

Cross-functional collaboration

Education

Bachelor's degree in Biomedical Engineering or Mechanical Engineering

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

Intepros in Mahwah, NJ is searching for a Senior Quality Engineer to support EU-MDR compliance initiatives and ensure products and manufacturing processes meet rigorous regulatory standards.

The role leads FAI and PPAP activities, manages change controls, validates equipment and processes, and collaborates with cross-site teams to drive quality improvements and maintain QMS compliance.