Design Quality Engineer: DHF & Design Controls (6 Mo)

Atlantic Group; Waltham (MA); On-site; USD 69,000 - 90,000; Full time

Job summary

Atlantic Group is actively hiring multiple Design Quality Engineers in Waltham, MA for a 6-month temporary assignment. The role focuses on DHF remediation, design controls and software-related quality documentation within a regulated medical device environment.

The ideal candidate has 5+ years in quality engineering or design assurance, with strong knowledge of FDA requirements, ISO 13485, and electronic quality systems. Collaboration across cross-functional teams is essential.

Qualifications

• Bachelor's degree in Engineering, Computer Science, Biomedical Engineering, Life Sciences, or related field.
• 5+ years of quality engineering or design assurance experience in regulated environments.
• Strong knowledge of medical device design controls, DHF, risk management and V&V.
• Familiarity with FDA quality requirements and ISO 13485 standards.
• Experience with quality documentation, audits, and EQMS processes.
• Excellent analytical, organizational and cross-functional collaboration skills.

Responsibilities

• Review design documentation and quality records to identify gaps and support design controls.
• Support DHF, design documentation, verification and validation activities.
• Review requirements, risk documents and testing records for accuracy and traceability.
• Assist audit readiness and regulatory inspections readiness.
• Maintain design and quality records within electronic quality systems.
• Collaborate with engineering, quality, regulatory, and other teams to resolve issues.

Skills

Quality engineering

Design controls

Regulatory knowledge

Documentation

Education

Bachelor's degree in Engineering or related field

Tools

Electronic quality management systems

Job description

Atlantic Group is actively hiring multiple Design Quality Engineers in Waltham, MA for a 6-month temporary assignment. The role focuses on DHF remediation, design controls and software-related quality documentation within a regulated medical device environment.

The ideal candidate has 5+ years in quality engineering or design assurance, with strong knowledge of FDA requirements, ISO 13485, and electronic quality systems. Collaboration across cross-functional teams is essential.