Global UDI & Supplier Quality Engineer

Anchor Point Technology Resources; New Jersey; On-site; USD 75,000 - 95,000; Full time

Job summary

Anchor Point Technology Resources is looking for a Supplier Quality Engineer in New Jersey. This role involves providing Supplier Quality support, leading UDI implementation with suppliers to ensure compliance with FDA requirements, and working closely with supplier engineering and quality teams.

The ideal candidate must have a Bachelor’s degree in Engineering, 2+ years of experience, and knowledge of U.S. medical device regulations. Skills in communication and leadership are crucial, along with the ability to travel up to 30% for supplier visits.

Qualifications

• 2+ years of manufacturing, quality assurance, and/or engineering experience required.
• Working knowledge of U.S. medical device regulations (21 CFR Parts 820, 803, and 806) required.
• Working knowledge of standard quality system requirements (ISO 9001, ISO 13485) preferred.

Responsibilities

• Provide Supplier Quality support and oversight to client locations.
• Lead global UDI implementation with suppliers.
• Interface with suppliers to develop new processes.

Skills

Manufacturing experience

Quality assurance

Engineering

U.S. medical device regulations

FDA UDI regulation

Supplier quality experience

Communication skills

Leadership

Education

Bachelor of Science in Engineering or related technical field

Job description

Anchor Point Technology Resources is looking for a Supplier Quality Engineer in New Jersey. This role involves providing Supplier Quality support, leading UDI implementation with suppliers to ensure compliance with FDA requirements, and working closely with supplier engineering and quality teams.

The ideal candidate must have a Bachelor’s degree in Engineering, 2+ years of experience, and knowledge of U.S. medical device regulations. Skills in communication and leadership are crucial, along with the ability to travel up to 30% for supplier visits.