Medical Device Quality Engineer: Design Control & CAPA

Novozen Healthcare LLC; Minnesota; On-site; USD 70,000 - 100,000; Full time

Job summary

Novozen Healthcare LLC in Minnesota seeks a contract Quality Engineer focused on design control and sustaining engineering for medical devices. You will support design changes, risk assessments, CAPA, and ensure documentation compliance.

Collaborate across Design, Manufacturing, Quality, and Regulatory teams to maintain DHF/DMR/DHR, pursue continuous improvement, and ensure FDA quality-system compliance. This is a contract position with no employer-provided benefits.

Qualifications

• Requires 2–3+ years in quality engineering or related field.
• Strong understanding of Design Control and FDA quality systems.
• Experience with DHF/DMR/DHR and controlled documents.

Responsibilities

• Support Design Control, Sustaining Engineering, and quality-system activities for medical devices
• Assess process gaps, compliance risks, rework, and manufacturing documentation
• Maintain DHF, DMR, DHR, work instructions, and controlled documents
• Support design changes, risk assessments, impact assessments, and change controls
• Support CAPA, process improvements, and quality deliverables
• Collaborate with Design, Manufacturing, Quality, and Regulatory teams
• Ensure proper documentation, traceability, and FDA quality-system compliance
• Identify process gaps and non-standard rework and drive corrective actions
• Support capital equipment and systems engineering activities with a design focus

Skills

Quality engineering

Design Control

Sustaining engineering

Documentation

Cross-functional collaboration

Education

Bachelor's degree in Engineering or related field

Job description

Novozen Healthcare LLC in Minnesota seeks a contract Quality Engineer focused on design control and sustaining engineering for medical devices. You will support design changes, risk assessments, CAPA, and ensure documentation compliance.

Collaborate across Design, Manufacturing, Quality, and Regulatory teams to maintain DHF/DMR/DHR, pursue continuous improvement, and ensure FDA quality-system compliance. This is a contract position with no employer-provided benefits.