Senior Design Quality Engineer

You're the right fit if

• You have a minimum of 5+ 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 proven experience in Design Verification/Validation, Root Cause analysis and Defect Management.
• 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 Post Market Surveillance (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. ASQ-CQE, ISO 13485 training, ISO Lead Auditor certification-desired
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

Your role

1. 1Plan and execute comprehensive process validation strategies using statistical tools to ensure seamless transition of new products to production, meeting quality and regulatory standards.
2. 2Leads 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 Post Market Surveillance (PMS) insights into all stages of the product lifecycle, driving continuous enhancement of product quality and reliability.
3. 3Drafts 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.
4. 4Conducts 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.
5. 5Validates critical design inputs such as usability, reliability, performance, manufacturability, and safety, ensuring alignment with both quality standards and regulatory requirements.
6. 6Guides comprehensive risk management activities throughout the product lifecycle, ensuring potential risks are accurately identified, assessed, and effectively mitigated to uphold product safety and quality.
7. 7Leverages 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.
8. 8Ensures preparation for quality audits and inspections, maintaining all necessary documentation and processes to demonstrate compliance with both internal and external quality standards.
9. 9Records, manages, and executes CAPA processes, including problem identification, root cause analysis, and implementation of solutions to prevent recurrence and drive continuous improvement.
10. 10Apply 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.
11. 11Builds 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.
12. 12Contributes to the development, implementation, and revision of QMS processes, including standard operating procedures (SOPs), work instructions, and quality manuals, ensuring their accuracy, clarity, and compliance with relevant standards.
13. 13Previous experience documenting design, process and/or QMS changes and executing applicable gap assessments.