Quality Systems Engineer: Drive Compliance & QMS Excellence

Delcath Systems; Town of Queensbury (NY); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Comprehensive health plan

401(k)

Professional development opportunities

Job summary

A healthcare technology company in Queensbury is seeking a Quality Systems Engineer to manage the Quality Management System and ensure compliance with FDA and ISO standards. The role involves resolving quality concerns and supporting audits. Candidates should have a bachelor's degree in engineering, three years' experience in a regulated environment, and proficiency in document control systems. The position offers a comprehensive benefits package including health coverage and 401(k).

Qualifications

• Minimum of three years of experience in quality assurance of an FDA regulated or ISO 13485 certified organization.
• Experience in audit support, document control, change control, CAPA, NCR.
• Certification in internal/external auditing is an advantage.
• Team-oriented with the ability to work with cross-functional teams.

Responsibilities

• Manage the Quality Management System and resolve quality concerns.
• Coordinate Document Change control processes and support quality systems software validations.
• Support internal and external audit programs.
• Develop knowledge of FDA cGMP and EU GMP regulations.

Skills

Problem-solving

Analytical skills

Strong communication

Team collaboration

Computer proficiency in Excel and Word

Education

Bachelor's degree in engineering or physical sciences

Tools

Document Control Systems

ERP System

Job description

A healthcare technology company in Queensbury is seeking a Quality Systems Engineer to manage the Quality Management System and ensure compliance with FDA and ISO standards. The role involves resolving quality concerns and supporting audits. Candidates should have a bachelor's degree in engineering, three years' experience in a regulated environment, and proficiency in document control systems. The position offers a comprehensive benefits package including health coverage and 401(k).