Urgent :: Medical Device Quality Systems Engineer (REMOTE)

Remote • Posted 1 hour ago • Updated 1 hour ago

Contract W2

No Travel Required

Remote

Depends on Experience

Fitment

Dice Job Match Score™

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Job Details

Skills

Collaboration
Communication
Design Controls
ISO 13485
ISO 9000
Mergers and Acquisitions
Medical Devices
Product Development
Quality Management
Regulatory Compliance
Systems Engineering
Verification And Validation
Medical Device Quality
controls and regulatory compliance

Summary

W2 ROLE!!

Medical Device Quality/Systems Engineer (REMOTE)
Duration: 12-Month Contract
Travel: Limited (2–3 trips during the engagement; CO or MA domestic, possible Costa Rica international; max 3 days per trip)
Start Date: March 16 (earliest) – March 23 (latest)

LINKEDIN REQUIRED!

Position Overview

We are seeking an experienced Quality/System Engineer with a strong background in medical device design controls and regulatory compliance. This role is responsible for ensuring full traceability from user needs through design inputs, verification, and validation across the product development lifecycle.

The ideal candidate brings 5–8 years of experience in regulated environments and deep expertise in FDA and ISO standards.

Required Qualifications

5–8 years of Quality or System Engineering experience in medical devices or highly regulated industries
Strong expertise in Design Controls, traceability, and V&V processes
Proven knowledge of FDA 21 CFR 820 and ISO 13485
Experience preparing and maintaining DHF documentation
Excellent cross-functional collaboration and communication skills
Strong written and verbal English communication

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
Dice Id: 91143216
Position Id: 8902820
Posted 1 hour ago

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