Senior Quality Assurance Engineer – EU-MDR Focus

GForce Life Sciences; Mahwah (NJ); On-site; USD 110,000 - 140,000; Full time

Job summary

GForce Life Sciences in Mahwah, NJ is seeking a Senior Quality Assurance Engineer to provide quality engineering support across QA, control, and preventative activities with a focus on EU-MDR initiatives for our medical device product portfolio.

The ideal candidate will have a Bachelor’s degree in engineering, 4+ years of industry experience, experience with EU-MDR programs, and excellent English communication skills to collaborate across functions and ensure robust compliance.

Qualifications

• Bachelor’s degree in an engineering field (Biomedical/Mechanical preferred).
• 4+ years of industry experience in quality assurance/quality engineering.
• Experience supporting EU-MDR programs/initiatives.
• Excellent English (oral and written).

Responsibilities

• Provide quality engineering support for EU-MDR initiatives across product portfolio.
• Develop and implement methods for process control, improvement, testing, and inspection.
• Support First Article Inspection (FAI) strategy and approvals.
• Support Production Part Approval Process (PPAP) activities.
• Support change control and perform change impact assessments.
• Maintain SOP and risk documentation updates and reviews.
• Support equipment and process validations.
• Lead initiatives to enhance quality performance and regulatory compliance.

Skills

Quality engineering

Process improvement

Regulatory experience

Education

Bachelor’s degree in engineering

Tools

FMEA

CAPA

PPAP

Job description

GForce Life Sciences in Mahwah, NJ is seeking a Senior Quality Assurance Engineer to provide quality engineering support across QA, control, and preventative activities with a focus on EU-MDR initiatives for our medical device product portfolio.

The ideal candidate will have a Bachelor’s degree in engineering, 4+ years of industry experience, experience with EU-MDR programs, and excellent English communication skills to collaborate across functions and ensure robust compliance.