Quality Project Engineer | GMP & Regulatory Excellence

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

Job summary

A medical device company in Town of Queensbury is seeking a Project Quality Engineer to ensure effective quality system establishment and FDA compliance. The role involves leading continuous improvement projects and supporting design verification processes. Candidates should have a Bachelor's degree in engineering or physical sciences and a minimum of five years' experience in quality assurance within FDA regulated industries. Strong analytical skills and proficiency in software tools are essential in this position.

Qualifications

• A minimum of five or more years of experience in quality assurance, quality engineering, project management or related functions in an FDA regulated industry or ISO certified organization.
• Must possess strong analytical and process skills, and be computer proficient in EXCEL and Word.
• Must be team oriented, with the ability to work well with diverse cross-functional teams.

Responsibilities

• Lead continuous improvement projects.
• Participate on new product design teams as the design quality assurance engineer.
• Support design verification, process validation, software validation and test method validation.
• Generate procedures, specifications, and labeling as required.
• Support the Corrective Action and Preventive Action Program.

Skills

Project Management

Analytical skills

Team-oriented

Education

Bachelor’s degree in engineering or physical sciences

Tools

EXCEL

Word

Job description

A medical device company in Town of Queensbury is seeking a Project Quality Engineer to ensure effective quality system establishment and FDA compliance. The role involves leading continuous improvement projects and supporting design verification processes. Candidates should have a Bachelor's degree in engineering or physical sciences and a minimum of five years' experience in quality assurance within FDA regulated industries. Strong analytical skills and proficiency in software tools are essential in this position.