Senior QA Engineer - Hybrid/Remote (Med Device)

System One; Mahwah (NJ); Hybrid; USD 76,000 - 83,000; Part time

Job summary

System One in Mahwah, NJ is seeking a Senior Quality Assurance Engineer for a contract role. The position combines hybrid onsite and remote work, with a minimum of three days per week onsite, focusing on quality assurance, control and preventative activities across operations.

The ideal candidate will hold a related engineering degree, have 4+ years of experience, and support EU-MDR programs. Strong communication, analytical skills, and proficiency in MS Office are required, along with

Qualifications

• Bachelor’s degree in a relevant engineering field.
• Strong communication and attention to detail required.
• Proficiency with MS Word/Excel/PowerPoint.

Responsibilities

• Develop and implement methods and procedures for process control, testing and inspection to ensure product quality.
• Lead quality initiatives to improve performance and ensure regulatory compliance.
• Support FAI, PPAP, change control, validation activities, and risk/documentation updates.

Skills

Communication skills

Attention to detail

Analytical skills

Team player

Multitasking

Cross-functional collaboration

Voice of Quality

Education

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

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

System One in Mahwah, NJ is seeking a Senior Quality Assurance Engineer for a contract role. The position combines hybrid onsite and remote work, with a minimum of three days per week onsite, focusing on quality assurance, control and preventative activities across operations.

The ideal candidate will hold a related engineering degree, have 4+ years of experience, and support EU-MDR programs. Strong communication, analytical skills, and proficiency in MS Office are required, along with