Senior Quality & Validation Engineer (EU-MDR) – Hybrid

Matlen Silver; Mahwah (NJ); Hybrid; USD 69,000 - 98,000; Part time

Job summary

Matlen Silver seeks a Quality/Validation Engineer in Mahwah, NJ on a 14-month contract with hybrid onsite schedule. You will support EU-MDR initiatives, perform FAI/PPAP activities, and ensure compliance across QA, QC and process validation.

The role requires a Bachelor's in Biomedical or Mechanical Engineering, 4+ years in medical device quality and strong ISO 13485 knowledge, plus proficiency with MS Office and cross-functional teamwork in a multi-site environment.

Qualifications

• Bachelor’s degree in Biomedical Engineering or Mechanical Engineering or related field
• 4+ years of experience in industry
• Experience supporting EU-MDR programs
• Knowledge of QMS and ISO 13485 concepts
• Proficient with MS Office suite

Responsibilities

• Provide quality engineering support in QA, control and preventative activities
• Support EU-MDR initiatives
• Develop and implement methods for process control, process improvement, testing and inspection
• Lead First Article Inspection (FAI) strategy development, execution and approvals
• Support Production Part Approval Process (PPAP)
• Execute change control and assess change impact
• Support SOP and risk documentation updates and reviews
• Equipment and process validations
• Collaborate with multi-site team to enhance quality performance

Skills

Quality engineering

FAI

PPAP

Change control

SOP & documentation

Risk management

EU MDR understanding

ISO 13485 knowledge

Statistical methods

Strong communication

Team collaboration

Education

Bachelor's Degree - Biomedical Engineering, Mechanical Engineering or related field

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Matlen Silver seeks a Quality/Validation Engineer in Mahwah, NJ on a 14-month contract with hybrid onsite schedule. You will support EU-MDR initiatives, perform FAI/PPAP activities, and ensure compliance across QA, QC and process validation.

The role requires a Bachelor's in Biomedical or Mechanical Engineering, 4+ years in medical device quality and strong ISO 13485 knowledge, plus proficiency with MS Office and cross-functional teamwork in a multi-site environment.