Quality Assurance Engineer – Onsite (Med Device)

Ledgent Technology; Mahwah (NJ); In loco; USD 52.000 - 59.000; Tempo pieno

Descrizione del lavoro

Ledgent Technology in Mahwah, NJ is seeking an Engineer, Quality Assurance – Onsite. This role requires providing quality engineering support in QA, control and preventative activities across operations and other functions.

You will develop and implement methods for process control, testing and inspection to ensure products are free of flaws and function as designed. The position demands a degree and the ability to work independently, applying procedures and professional judgment.

Competenze

• Bachelor’s degree in Biomedical or Mechanical Engineering or related field.
• 2 years of industry experience.
• Familiar with QMS principles and change management.
• Understanding of Med Device concepts is desirable.
• ISO 13485 and EU regulations familiarity desirable.
• Excellent written and verbal communication.
• Strong engineering and quality knowledge; good PC skills.

Mansioni

• Develop and implement methods for process control, testing and inspection.
• Lead First Article Inspection (FAI) strategy and PPAP activities.
• Manage change control processes and assess impact of changes.
• Validate equipment and processes; support SOP and risk management updates.
• Collaborate across sites to drive quality improvements.

Conoscenze

Quality mindset

Communication

Problem solving

Team player

Self-starter

Formazione

Bachelor’s Degree – Biomedical Engineering

Bachelor’s Degree – Mechanical Engineering

Strumenti

Microsoft Word

Microsoft Excel

PowerPoint

Descrizione del lavoro

Ledgent Technology in Mahwah, NJ is seeking an Engineer, Quality Assurance – Onsite. This role requires providing quality engineering support in QA, control and preventative activities across operations and other functions.

You will develop and implement methods for process control, testing and inspection to ensure products are free of flaws and function as designed. The position demands a degree and the ability to work independently, applying procedures and professional judgment.