Design Quality Assurance Engineer

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.

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.