Hybrid Remote Lead QA Engineer — Medical Devices QMS

Legacy MEDSearch; Washington (District of Columbia); Hybrid; USD 90,000 - 120,000; Full time

Job summary

A leading quality assurance firm is seeking a Lead Quality Assurance Engineer to establish and improve the Quality Management System. Responsibilities include mentoring teams, overseeing quality processes, and ensuring compliance with regulations. The ideal candidate has 7+ years of relevant experience in quality and engineering within the medical device field. This full-time position offers a hybrid work model.

Qualifications

• 7+ years related Quality / Engineering work experience.
• 5+ years of experience with medical device regulatory and quality and Quality Management Systems.
• Experience maintaining Technical Files, Risk Management Files, and Change Control documentation.

Responsibilities

• Mentor design teams on Design Controls and Risk Management.
• Oversee manufacturing quality processes and nonconforming material handling.
• Manage QMS activities such as audits and CAPA.

Skills

Mentoring

Regulatory Compliance

Statistical Analysis

Creative Problem Solving

Education

Bachelor’s degree in Quality, Engineering, or related discipline

Tools

QMS documentation

ISO standards knowledge

Job description

A leading quality assurance firm is seeking a Lead Quality Assurance Engineer to establish and improve the Quality Management System. Responsibilities include mentoring teams, overseeing quality processes, and ensuring compliance with regulations. The ideal candidate has 7+ years of relevant experience in quality and engineering within the medical device field. This full-time position offers a hybrid work model.