Design Quality Engineer

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

Job Overview - Design Quality Engineer

Compensation: $50-$65/hour

Location: Waltham, MA

Schedule: Temporary Assignment (6 Months)

Atlantic Group is hiring multiple Design Quality Engineers in Waltham, MA for our client, supporting a critical quality remediation initiative within a regulated medical device environment. This role will focus on Design History File (DHF) remediation, software design controls, documentation traceability, quality system compliance, and regulatory inspection readiness. The ideal candidate has 5+ years of quality engineering or design assurance experience with strong knowledge of medical device design controls and software-related quality documentation.

Responsibilities as the Design Quality Engineer:

• Design Quality: Review design documentation and quality records to identify gaps and support compliance with established design control requirements.
• Design Controls: Support Design History Files, design documentation, verification and validation, and related quality engineering activities.
• Quality Documentation: Review requirements, risk documentation, testing records, and supporting quality documentation for accuracy and traceability.
• Regulatory Compliance: Support audit and inspection readiness while addressing quality and documentation issues.
• Document Control: Maintain accurate design and quality records within electronic quality systems while supporting document control activities.
• Cross-Functional Collaboration: Partner with engineering, quality, regulatory, and other technical teams to resolve quality issues and improve design control processes.

Qualifications for the Design Quality Engineer:

• Education: Bachelor's degree in Engineering, Computer Science, Biomedical Engineering, Life Sciences, or a related technical field is required.
• Experience: 5+ years of quality engineering, design assurance, design controls, or related regulated product experience is required.
• Industry Knowledge: Medical device or related regulated product experience is required, with strong knowledge of Design History Files, design controls, verification and validation, and risk management.
• Regulatory Knowledge: Knowledge of FDA medical device quality requirements and ISO 13485 is required.
• Technical Skills: Experience with quality documentation, audits, design control processes, and electronic quality management systems is required.
• Skills & Attributes: Strong analytical, documentation, organizational, communication, problem-solving, attention to detail, and cross-functional collaboration skills are required.

Qualified candidates will be contacted within 2 business days of application. If an applicant does not meet the above criteria, Atlantic Group will keep your resume on file for future opportunities and may contact you for further discussion.