Design Quality Assurance Engineer III - Endoscopy
About The Position
The Design Quality Assurance Engineer III provides quality engineering support and expertise across the product lifecycle, including new product development, design transfer, product changes, sustaining engineering, material continuity, regulatory compliance, corrective and preventive actions, and post-market support activities. Working in a fast-paced cross-functional environment, this role partners with Research & Development, Operations, Supplier Quality, Manufacturing, Regulatory Affairs, Clinical, and Marketing teams to ensure products are safe, effective, compliant, and meet customer and business needs. The engineer serves as a quality representative, championing patient safety, product quality, risk-based decision making, and continuous improvement.
Requirements
- Bachelor's degree in Engineering or related technical discipline.
- Minimum 5 years of experience in Design Assurance, Quality Engineering, Product Development, or a related role within a regulated industry.
- Knowledge of Design Controls, Risk Management, Quality Systems, and Good Documentation Practices.
- Strong analytical, technical writing, communication, and problem-solving skills.
- Experience working effectively within cross-functional teams.
Nice To Haves
- Bachelor's degree in Mechanical, Electrical, Biomedical, or related Engineering discipline.
- Medical device industry experience.
- Experience with Design Controls, Risk Management, CAPA, and medical device standards compliance.
- Knowledge of FDA Quality System Regulations, ISO 13485, ISO 14971, IEC 62366, and/or IEC 62304.
- ASQ Certified Quality Engineer (CQE) and/or Six Sigma Green Belt or Black Belt certification.
Responsibilities
- Provide quality engineering support for new product development, product enhancements, design transfers, design changes, and sustaining engineering projects.
- Partner with cross-functional teams to ensure compliance with Product Development Process, Design Controls, Risk Management, and applicable Quality System requirements.
- Lead or support design change projects including project scoping, impact assessment, implementation, and effectiveness verification.
- Develop, review, update, and maintain Design History File documentation and design input/output records.
- Lead or support risk management activities including Hazard Analyses, Use-Related Risk Analyses, Task Analyses, Design FMEAs, and benefit-risk assessments.
- Develop and execute Design Verification, Design Validation, Usability, and other qualification protocols and reports.
- Serve as a quality representative on project teams, providing guidance on quality system requirements, design controls, standards compliance, and regulatory expectations.
- Support investigations and resolution of complaints, nonconformances, CAPAs, product investigation reports, audit observations, field actions, and supplier quality issues.
- Apply structured problem-solving methodologies to identify root causes, assess risk, and implement effective corrective actions.
- Monitor post-market data, complaint trends, and product performance signals to assess risk and drive quality improvements.
- Support supplier qualification, audits, co-development activities, and ongoing supplier performance monitoring.
- Participate in internal, external, customer, and regulatory audits and inspection readiness activities.
- Drive continuous improvement initiatives focused on product quality, manufacturability, reliability, compliance, and cost effectiveness.
Benefits
- Relocation assistance may be available for this position at this time.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
