Design Quality Engineer

As a Design Quality Engineer at Treace, your responsibilities will primarily include managing quality projects, conducting root cause investigations, assessing product changes, maintaining calibration statuses, creating inspection documents, supporting product development initiatives, and collaborating with supplier quality representatives. You’ll play a key role in ensuring that the products meet all quality assurance objectives while supporting the growth and innovation of the Lapiplasty® System.

To qualify for the Design Quality Engineer position at Treace, you should have a Bachelor's degree in Engineering, Science, Technology, or a related field, along with at least 3 years of progressive experience in medical device engineering. Familiarity with FDA compliance, particularly Title 21 section 820, is essential. Your background in quality assurance and ability to conduct detailed investigations will also be crucial for success in this role.

The Design Quality Engineer plays a vital role in improving patient outcomes by ensuring the highest standards of product quality and safety. By conducting thorough inspections, overseeing the change control process, and actively engaging in product development, you directly support surgeons in using the Lapiplasty® System effectively, ultimately leading to better surgical results and enhanced patient care.

At Treace, a Design Quality Engineer will engage in a variety of projects, including root cause analysis for non-conformances, product change evaluations, calibration activities, and the development of inspection models. You will collaborate with cross-functional teams to implement continuous improvement programs and participate in hands-on product testing to ensure the quality and effectiveness of medical devices.

Yes, having hands-on experience in labs is highly beneficial for a Design Quality Engineer at Treace. Participating in cadaver labs allows you to understand the practical applications of the products and how they operate in real-world situations. This experience strengthens your ability to identify quality issues and make informed recommendations, enhancing overall product safety and effectiveness.

In your answer, focus on specific experiences where you have worked within FDA-compliant environments, particularly under Title 21 section 820. Discuss any practical applications, audits, or quality assurance processes you’ve been involved in, highlighting how you ensured compliance and contributed to product safety.

Explain your systematic approach to root cause analysis, mentioning methodologies like the 5 Whys or Fishbone diagrams. Share a specific instance where you successfully identified and addressed a root cause, detailing the steps you took and the outcomes achieved.

Discuss the importance of calibration in ensuring product quality. Describe techniques you follow, such as creating maintenance schedules, using calibrated standards, and verifying results of calibration activities. Providing a case study where this process was critical can strengthen your response.

Detail your process for assessing product changes, including risk analysis and impact assessments. Explain how you work collaboratively with design and engineering teams to determine appropriate actions and ensure that product modifications comply with quality standards.

Provide an example of a continuous improvement project you led or participated in. Focus on the goals of the initiative, your role in the team, tools used (like Kaizen or Lean methodologies), and the positive results achieved, such as reduced defect rates or improved efficiency.

Highlight qualities such as attention to detail, strong analytical skills, teamwork, and effective communication. You might also mention the ability to remain objective under pressure and a proactive attitude toward quality issues.

Explain your process for investigating non-conformance reports, including gathering data, conducting inspections, and working toward corrective actions. Emphasize the importance of timely and effective communication with affected teams to resolve issues quickly.

Discuss your experience in creating inspection models and prints, along with detailed testing requirements. Provide examples demonstrating your attention to detail and how you ensure that the products meet quality standards before they reach the market.

Share examples of how you've worked with engineering, manufacturing, and supply chain teams. Emphasize the importance of open communication, understanding different perspectives, and how you contribute quality assurance insights during the product development process.

Mention specific tools and software relevant to quality engineering, such as statistical process control (SPC) software, quality management systems (QMS), and data analysis tools. Discuss how you've used these tools to improve processes or conduct analyses.