Quality Engineer – Medical Devices (FDA/ISO 13485)

Threadstone; Severna Park (MD); On-site; USD 70,000 - 90,000; Full time

Job summary

Threadstone in Severna Park, MD, is seeking a full-time Quality Engineer to develop, implement, and maintain quality systems that meet FDA and ISO 13485. You will collaborate with manufacturing, engineering, and regulatory teams to resolve quality issues and improve product reliability.

Responsibilities include conducting inspections, product and process validations, managing nonconformance investigations, supporting CAPA, and updating SOPs and quality records.

Qualifications

• Experience building and improving quality systems and processes.
• Experience with in-process and final inspections and data reviews.
• Familiarity with FDA and ISO 13485 standards in medical device manufacturing.
• Ability to perform risk-based decision-making and CAPA tracking.

Responsibilities

• Develop, implement, and maintain quality systems supporting FDA and ISO 13485.
• Conduct inspections, validations, and data reviews for product quality.
• Lead CAPA investigations and corrective actions.
• Support internal and external audits and maintain quality records.

Skills

Quality Engineering

Quality Management

Root Cause Analysis

CAPA Management

FDA & ISO 13485 knowledge

Documentation & Audit support

Education

Bachelor’s degree in engineering or related technical field

Job description

Threadstone in Severna Park, MD, is seeking a full-time Quality Engineer to develop, implement, and maintain quality systems that meet FDA and ISO 13485. You will collaborate with manufacturing, engineering, and regulatory teams to resolve quality issues and improve product reliability.

Responsibilities include conducting inspections, product and process validations, managing nonconformance investigations, supporting CAPA, and updating SOPs and quality records.