Quality Assurance Engineer - Onsite, Med Device Focus

Ledgent Technology; Mahwah (NJ); On-site; USD 52,000 - 59,000; Full time

Job summary

Ledgent Technology in Mahwah, NJ is seeking a Quality Assurance Engineer onsite to support quality engineering activities across operations and related functions. You will develop and implement methods for process control, testing and inspection to ensure products meet design and regulatory standards.

This role requires a bachelor's in biomedical or mechanical engineering and at least two years of experience, with knowledge of QMS, change control, PPAP, FAI, and ISO 13485.

Qualifications

• Bachelor’s Degree in Biomedical Engineering, Mechanical Engineering or related field.
• 2+ years of industry experience.
• Knowledge of Change Management and Quality Management Systems (QMS) principles.
• ISO 13485 and EU Regulations, GDP, GMP knowledge desirable.
• Excellent communication and attention to detail.
• Proficient with MS Word, MS Excel and PowerPoint.
• Strong cross-functional collaboration and problem solving.

Responsibilities

• Develop and implement methods and procedures for process control, testing and inspection.
• Support First Article Inspection (FAI) strategy development, execution and approvals.
• Support PPAP and change control processes and change impact assessments.
• Validate equipment and processes; update SOPs and risk management documentation.
• Collaborate with multi-site teams and stakeholders to drive quality improvements.

Skills

Attention to detail

Communication skills

Problem solving

Team player

Multitasking

English proficiency

Education

Bachelor's degree in Biomedical Engineering, Mechanical Engineering or related field

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Ledgent Technology in Mahwah, NJ is seeking a Quality Assurance Engineer onsite to support quality engineering activities across operations and related functions. You will develop and implement methods for process control, testing and inspection to ensure products meet design and regulatory standards.

This role requires a bachelor's in biomedical or mechanical engineering and at least two years of experience, with knowledge of QMS, change control, PPAP, FAI, and ISO 13485.