INGENYX- Design Quality Assurance Engineer II

Position Summary

The Design Quality Assurance (DQA) Engineer is responsible for ensuring that product design and development activities comply with applicable regulatory and quality requirements, including ISO 13485, EU MDR (2017/745), MDSAP, and FDA 21 CFR Part 820 (QSR). This role partners closely with R&D, Manufacturing, Regulatory Affairs, and Program Management to ensure design control compliance, effective risk management, and successful product development from concept through commercialization.

Principal Responsibilities

• Ensure compliance with Design Controls (21 CFR 820.30) and ISO 13485 design and development requirements.
• Provide quality oversight for design and development activities throughout the product lifecycle.
• Participate in and approve design reviews, ensuring deliverables meet regulatory and internal quality standards.
• Ensure completeness and compliance of Design History Files (DHF).
• Lead and support design control deliverables, including design and development plans, design inputs and outputs, design verification and validation (DV&V), and design transfer.
• Ensure robust traceability matrices linking user needs, design inputs, outputs, verification, and validation.
• Facilitate and review risk management activities in accordance with ISO 14971: hazard analysis, risk assessments and mitigations, risk-benefit analysis.
• Review and approve design verification and validation protocols and reports.
• Ensure test methods are scientifically sound and compliant with regulatory expectations.
• Evaluate statistical justifications for sample sizes and acceptance criteria.
• Ensure alignment of validation activities with intended use and user needs.
• Ensure appropriate design change control processes are followed, including re-verification/re-validation as required.
• Assess impact of changes on regulatory submissions and product risk.
• Ensure smooth design transfer to manufacturing with complete and compliant documentation.
• Review Device Master Record (DMR) elements for accuracy and completeness.
• Partner with Manufacturing and Process Engineering on validation strategies (IQ/OQ/PQ alignment with design intent).
• Support internal and external audits (FDA, Notified Body, MDSAP) related to design controls.
• Act as SME for design quality systems during inspections.
• Analyze design-related quality metrics (e.g., complaints, CAPAs, field issues).
• Support CAPA investigations related to design deficiencies.

Education / Experience Requirements

• Bachelor's degree in Engineering or related technical field (Mechanical, Biomedical, Electrical, etc.).
• Minimum 2-5 years of experience in medical device quality or design assurance.
• Knowledge of ISO 13485, FDA 21 CFR Part 820 (QSR), EU MDR, MDSAP, ISO 14971.

Specialized Skills / Other Requirements

• Experience supporting Class II/III medical devices.
• Direct involvement in FDA inspections, Notified Body audits, or MDSAP audits.
• ASQ certifications (CQE, CQA) or equivalent preferred.
• Strong analytical and critical thinking skills.
• Excellent written and verbal communication.
• Ability to influence cross-functional teams without direct authority.
• High attention to detail with strong documentation skills.
• Ability to manage multiple projects in a fast-paced environment.