Senior Quality Engineer - EU-MDR & PPAP (Hybrid)

The Matlen Silver Group, Inc.; Mahwah (NJ); Hybrid; USD 59,000 - 84,000; Full time

Job summary

The Matlen Silver Group, Inc. is seeking a Senior Quality/Validation Engineer in Mahwah, NJ on a 14-month contract. The role focuses on quality assurance, process control, and EU-MDR initiatives.

You will develop and implement methods to ensure product compliance, defect-free performance, and robust validation workflows. Responsibilities include FAI strategy, PPAP, change control, SOP and risk doc updates, and equipment/process validations.

Qualifications

• Experience applying QMS principles and change control processes.
• Knowledge of regulatory expectations for EU-MDR programs.
• Strong communication and attention to detail in a fast-paced environment.

Responsibilities

• Lead FAI strategy development, execution, and approvals.
• Support PPAP and change control activities.
• Update SOPs and risk documentation; assist in risk assessments.
• Oversee equipment and process validations and related documentation.

Skills

Quality engineering

Documentation

Regulatory compliance

Analytical thinking

Education

Bachelor’s Degree in Biomedical/Mechanical Engineering or related

Job description

The Matlen Silver Group, Inc. is seeking a Senior Quality/Validation Engineer in Mahwah, NJ on a 14-month contract. The role focuses on quality assurance, process control, and EU-MDR initiatives.

You will develop and implement methods to ensure product compliance, defect-free performance, and robust validation workflows. Responsibilities include FAI strategy, PPAP, change control, SOP and risk doc updates, and equipment/process validations.