Senior Design Quality Engineer

Senior Design Quality Engineer Job Description

The Senior Design Quality Engineer is responsible for the entire design control process, from validating design inputs to overseeing verification, validation, and design transfer, as well as leading comprehensive process validation strategies to ensure new products meet quality and regulatory standards during production.

Your role:

• Plan and execute comprehensive process validation strategies using statistical tools to ensure seamless transition of new products to production, meeting quality and regulatory standards.
• Leads the entire design control process, from eliciting and validating design inputs to managing verification, validation, and smooth design transfer, ensuring rigorous adherence to regulatory and quality standards. Leads quality improvement projects by integrating quality, reliability, and PMS insights into all stages of the product lifecycle, driving continuous enhancement of product quality and reliability.
• Drafts and upholds detailed quality engineering documents, including quality plans for hardware, software, and systems, ensuring all documentation is accurate, up-to-date, and compliant with regulatory requirements.
• Conducts thorough assessments of product and system designs, reviews performance data, and performs root cause analysis to identify and address quality deficiencies, ensuring the highest standards of design excellence.
• Validates critical design inputs such as usability, reliability, performance, manufacturability, and safety, ensuring alignment with both quality standards and regulatory requirements.
• Guides comprehensive risk management activities throughout the product lifecycle, ensuring potential risks are accurately identified, assessed, and effectively mitigated to uphold product safety and quality.
• Leverages post-market performance data to assess product effectiveness in the field, providing actionable feedback to manufacturing and design teams, and initiating corrective actions when necessary.
• Ensures preparation for quality audits and inspections, maintaining all necessary documentation and processes to demonstrate compliance with both internal and external quality standards.
• Records, manages, and executes CAPA processes, including problem identification, root cause analysis, and implementation of solutions to prevent recurrence and drive continuous improvement.
• Apply continuous improvement techniques to enhance quality practices, ensuring ongoing audit readiness and strict adherence to both internal and external quality standards throughout the product lifecycle.
• Builds and nurtures effective relationships with internal and external stakeholders, providing expert guidance and mentorship to cross‑functional teams, ensuring alignment with quality standards and successful project milestones.

You’re the right fit if:

• You have a minimum of 7+ years’ experience in FDA regulated medical device environments, with a focus on Design Assurance/Control, detailed knowledge of Risk Management (ISO 14971), and strong Understanding of all aspects of the QMS related to Design Controls.
• You have extensive experience supporting the creation and review of all medical device documentation including Component qualification, Hardware/Firmware, Design Verification Test/regression plans, test protocols/reports, process validation, issue tracking/resolution and auditing Design History Files (DHF).
• You have detailed experience in identifying, promoting, and supporting processes and design quality tools for use in tracking/preventing product defects, design traceability, and Design for Reliability.
• You have extensive experience in CAPA processes, including problem identification, root cause analysis, implementation of solutions to prevent recurrence and drive continuous improvement.
• You’re experienced in utilizing Quality, Reliability and PMS insights/data analytics to lead continuous improvement throughout all stages of the product lifecycle.
• You’re able to share knowledge, insights regarding quality standards, and regulatory requirements.
• You have a minimum of a Bachelor’s Degree (Required), in Quality, Engineering or similar disciplines.
• You must be…