We are seeking a Senior Design Quality Engineer to join our team. The ideal candidate will have a Bachelor's or Master's degree in Mechanical Engineering, Electronics Engineering, Science or equivalent, and a minimum of 2 years of experience in Quality Engineering, Safety Engineering, R&D Engineering or equivalent.
Requirements
- Create and execute comprehensive process validation strategies using statistical tools to ensure seamless transition of new products to production, meeting quality and regulatory standards, working under limited supervision.
- 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.
- Keep a check on the drafting and updating of 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.
- Conduct 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.
- 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 to uphold product safety and quality.
- Leverage 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.
- 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 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.
Benefits
- Opportunity to work on a wide range of products and technologies
- Collaborative and dynamic work environment
- Professional development and growth opportunities
- Competitive salary and benefits package
- Recognition and reward for outstanding performance
