Sr. Design Quality Engineer

As a Sr. Design Quality Engineer at Treace Medical Concepts, your primary responsibilities will include supporting product development by ensuring quality oversight, managing product and process risk files, leading qualification activities, and coordinating quality assurance with suppliers. You'll focus on ensuring all products meet design control and regulatory requirements while collaborating with cross-functional teams.

To qualify for the Sr. Design Quality Engineer role at Treace, candidates should possess a bachelor's degree in engineering, science, technology, or a related discipline. Additionally, a minimum of 5 years of progressive experience in medical device engineering is required, ideally within an FDA compliant environment. Certification as a Quality Engineer is preferred.

Treace emphasizes quality and compliance by integrating rigorous quality assurance processes at every stage of product development. A Sr. Design Quality Engineer plays a crucial role in monitoring compliance with FDA and ISO regulations, developing inspection models, and conducting root cause investigations, thereby ensuring that all products meet the highest standards.

The work culture at Treace Medical Concepts is vibrant and focused on collaboration, integrity, and continuous improvement. As a Sr. Design Quality Engineer, you can expect to work with high-performing teams, engage in meaningful discussions, and contribute to a workplace where everyone is encouraged to learn, grow, and excel while maintaining a sense of fun.

At Treace Medical Concepts, the potential for career advancement as a Sr. Design Quality Engineer is significant. Employees are encouraged to take on new challenges, collaborate with diverse teams, and continuously improve their skills. Contributions to innovative medical solutions can lead to opportunities for increased responsibilities and leadership roles within the organization.

In responding to this question, highlight your familiarity with FDA Title 21, section 820 requirements. Discuss specific projects where you ensured product compliance and how you navigated regulatory challenges, showcasing your proactive approach to quality management.

When answering this question, emphasize your systematic approach to risk management by outlining methods you've used to identify, assess, and mitigate risks during product development. Provide examples of risk management files you’ve created and how they aligned with FDA and ISO standards.

In your response, give a detailed account of a specific situation involving a non-conformance issue. Talk about your role in investigating the issue, implementing corrective actions, and how you collaboratively worked with relevant teams to prevent future occurrences.

Discuss the importance of open communication channels and regular updates in your strategy. Provide examples of how you’ve facilitated discussions, encouraged team input, and ensured all team members are on the same page regarding quality standards and expectations.

Explain your methodical approach to leading root cause investigations by illustrating a specific example. Detail your process for gathering data, analyzing problems, involving team members, and implementing corrective actions through the CAPA process.

Your response should focus on techniques like facilitating discussions, recognizing contributions, and fostering an inclusive environment where everyone’s voice is valued. Cite examples of how you’ve rallied teams around quality initiatives to boost morale and engagement.

Describe your prioritization strategy based on project deadlines, regulatory requirements, and team capabilities. Provide an example of how you managed competing priorities effectively, acknowledging the need for a sense of urgency in the medical device sector.

Discuss your experience with designing inspection models, emphasizing the importance of understanding product specifications and compliance standards. Provide specific examples of models you’ve created and the impact they had on quality assurance.

Articulate the steps you take to stay informed about industry standards, such as participating in professional organizations, attending conferences, and engaging in continuous learning opportunities. Share how this knowledge has positively impacted your work.

For this question, identify a specific process improvement project you were involved in, outlining the steps you took to assess the situation, implement changes, and measure the outcomes. Discuss how your contributions led to enhanced quality and efficiency.