Quality Engineer – Design Control

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

• 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


• 2–3+ years of experience in quality engineering, design control, systems engineering, sustaining engineering, or a related field


• Experience working in the medical device industry or another regulated environment


• Strong understanding of Design Control and Quality Systems


• Experience with change control, risk management, CAPA, and impact assessments


• Experience reviewing and maintaining DHF, DMR, DHR, work instructions, and manufacturing documentation


• Experience supporting design changes and sustaining engineering activities


• Understanding of FDA and applicable medical device quality-system requirements


• Experience identifying process gaps, compliance risks, and documentation issues


• Strong cross-functional collaboration skills with Design, Manufacturing, Quality, and Regulatory teams


• Systems engineering and design-focused experience is preferred


• Experience with capital equipment and quality-system activities is preferred


• Quality Systems


• Medical Device Industry Experience

No employer-provided benefits for this contract position.

We are committed to providing equal employment opportunities to all qualified individuals. We base employment decisions on job-related qualifications, business needs, and other lawful considerations, without regard to any characteristic protected by applicable federal, state, or local law.