Product Design Quality Engineer

Summary:

• Work Mode: Hybrid

Responsibilities:

• Create and execute comprehensive process validation strategies using statistical tools to ensure the seamless transition of new products to production, meeting quality and regulatory standards.
• Handle 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.
• Draft and update 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.
• Ensure the success of 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.
• Conduct thorough assessments of product and system designs, review performance data, and perform root cause analysis to identify and address quality deficiencies.
• Validate critical design inputs such as usability, reliability, performance, manufacturability, and safety, ensuring alignment with both quality standards and regulatory requirements.
• Guide comprehensive risk management activities throughout the product lifecycle, ensuring potential risks are accurately identified, assessed, and effectively mitigated.
• Leverage post-market performance data to assess product effectiveness in the field, providing actionable feedback to manufacturing and design teams.
• Ensure preparation for quality audits and inspections, maintaining all necessary documentation and processes to demonstrate compliance with both internal and external quality standards.
• Record, manage, and execute CAPA processes, including problem identification, root cause analysis, and the implementation of solutions to prevent recurrence.
• Apply continuous improvement techniques to enhance quality practices, ensuring ongoing audit readiness and strict adherence to both internal and external quality standards.
• Build effective relationships with internal and external stakeholders, providing guidance and mentorship to ensure alignment with quality standards and project milestones.

Requirements:

• Bachelor's or Master's Degree in Mechanical Engineering, Electronics Engineering, Science, or equivalent.
• Minimum 5 years of experience with a Bachelor's degree in areas such as Quality Engineering, Safety Engineering, R&D Engineering, or equivalent OR no prior experience required with a Master's Degree.

Preferred Skills:

• Six Sigma Green Belt certification
• Design Quality Management
• Data Analysis & Interpretation
• Design for Quality (DFQ)
• Root Cause Analysis (RCA)
• CAPA Methodologies
• Regulatory Requirements
• Privacy, Safety, and Security
• Risk Assessment
• Technical Documentation
• Continuous Improvement
• Product Quality and Reliability
• Defect Management
• Design Verification Planning
• Design Validation Planning
• Product Test Design