Design History Jobs in Massachusetts (NOW HIRING)

Job Summary

Our client is seeking an experienced Design Quality Assurance Engineer to serve as the embedded quality authority throughout the entire product development lifecycle. This position plays a critical role in ensuring Design Control compliance for contract development and manufacturing programs supporting the medical device, aerospace, and defense industries.

Working closely with Design Engineers, Program Managers, Manufacturing Engineering, and Quality teams, you will ensure products progress from concept through design transfer while meeting all regulatory, customer, and internal quality requirements. The ideal candidate possesses extensive knowledge of Design Controls, Design History Files (DHF), risk management, verification and validation (V&V), and FDA and ISO quality standards.

Key Responsibilities

Design Control & Quality Compliance

• Serve as the Design Quality representative on cross-functional product development teams.
• Ensure all product development activities comply with FDA Design Control regulations, ISO standards, customer requirements, and internal quality procedures.
• Review and approve Design Control documentation including:
  • Design Plans
  • Design Inputs
  • Design Outputs
  • Design Reviews
  • Verification & Validation (V&V) protocols and reports
  • Design Transfer documentation
  • Engineering Change Orders (ECOs)
• Maintain, audit, and ensure completeness of Design History Files (DHF).
• Identify Design Control risks, gaps, and compliance issues while driving timely resolution.

Engineering Support & Training

• Develop and deliver Design Controls training programs for Design Engineering teams.
• Provide day-to-day coaching and guidance on Design Control documentation and regulatory compliance.
• Participate in Design Reviews as the Quality representative.
• Ensure review action items are documented, tracked, and completed.

Risk Management & Verification

• Support Risk Management activities including:
  • FMEA
  • Hazard Analysis
  • Risk Assessments
• Ensure compliance with:
  • ISO 14971
  • AS9100
  • Customer-specific quality requirements
• Review and approve Verification & Validation protocols and reports.
• Ensure complete traceability between design inputs, outputs, and testing.
• Investigate testing failures and ensure corrective actions are properly documented.

Design Transfer & Manufacturing Support

• Lead quality activities supporting Design Transfer into Manufacturing.
• Ensure Device Master Records (DMR) and technical documentation packages are complete and approved.
• Partner with Manufacturing Engineering and Operations to verify production readiness.
• Confirm manufacturing processes, inspection methods, and equipment qualifications meet regulatory requirements prior to release.

Audits & Continuous Improvement

• Support internal, customer, and regulatory audits.
• Prepare Design Control documentation for audit readiness.
• Investigate design-related nonconformances.
• Perform root cause analysis and support Corrective and Preventive Actions (CAPA).
• Drive continuous quality improvement initiatives throughout product development.

Required Qualifications

• Bachelor's Degree in Engineering or another technical discipline (or equivalent combination of education and experience).
• Minimum 5 years of Quality Engineering experience supporting product design and development within the medical device industry.
• Strong knowledge of:
  • FDA 21 CFR Part 820
  • ISO 13485
  • ISO 14971
  • AS9100
• Experience maintaining Design History Files (DHF).
• Experience reviewing and approving Verification & Validation documentation.
• Experience supporting Design Transfer activities.
• Proficiency using Microsoft Office 365.
• Excellent organizational, analytical, and communication skills.

Preferred Qualifications

• Experience within contract development and/or contract manufacturing organizations.
• Aerospace or Defense manufacturing experience.
• Experience using electronic:
  • Quality Management Systems (eQMS)
  • Product Lifecycle Management (PLM)
  • Enterprise Resource Planning (ERP) systems.
• ASQ Certified Quality Engineer (CQE)
• Regulatory Affairs Certification (RAC) or equivalent quality certification.

Technical Skills

Candidates should possess expertise in:

Quality Systems

• FDA 21 CFR Part 820
• ISO 13485
• ISO 14971
• AS9100
• Design Controls
• CAPA
• Risk Management
• DHF Management
• DMR Documentation

Product Development

• Design Planning
• Design Inputs & Outputs
• Verification & Validation
• Design Reviews
• Engineering Change Orders
• Design Transfer
• Product Lifecycle Management

Quality Engineering

• Root Cause Analysis
• Nonconformance Investigations
• Internal Audits
• Customer Audits
• Regulatory Compliance
• Process Improvement

Software & Systems

• Microsoft Office 365
• eQMS
• PLM Systems
• ERP Systems

Leadership & Professional Skills

• Strong leadership and cross-functional collaboration skills.
• Ability to train and mentor engineering teams on Design Control requirements.
• Excellent verbal and written communication skills.
• Exceptional attention to detail and documentation quality.
• Strong organizational and project management abilities.
• Ability to balance regulatory compliance with aggressive product development timelines.
• Independent decision-making and problem-solving skills.

Working Conditions

• Primarily office environment with work performed in engineering laboratories and controlled manufacturing environments.
• Regular work within ISO Class 7 cleanrooms.
• Personal Protective Equipment (PPE) required in controlled manufacturing and cleanroom environments.
• Occasional travel (less than 10%) to support customer audits, supplier visits, or program reviews.