Senior Quality Engineer

The Senior Quality Engineer at our company carries a diverse range of responsibilities including understanding the end-to-end complaint lifecycle, collecting data from sources like Trackwise, and translating this data into comprehensive Power BI dashboards. This role also entails authoring and peer reviewing post-market plans and reports on medical devices sold globally, as well as providing technical expertise in data analysis and performance monitoring.

To qualify for the Senior Quality Engineer position at our company, candidates should have 4-7 years of experience in the medical device domain, with a strong understanding of post-market surveillance aligned with US FDA and EU MDR standards. Familiarity with quality management systems such as ISO 13485 or 21 CFR 820, along with proficiency in tools like TrackWise, Advance Excel, Power BI, Tableau, and Minitab, is also essential.

While not strictly required, project management experience is highly preferred for the Senior Quality Engineer position at our company. Having the ability to influence and motivate cross-functional teams is incredibly valuable, particularly when leading global process improvement efforts and working collaboratively across geographically dispersed teams.

A Senior Quality Engineer in our company should possess strong analytical and statistical skills, with proficiency in advanced Excel, Power BI, Tableau, and Minitab being particularly beneficial. Understanding medical device risk management is also crucial to effectively fulfill the role.

The Senior Quality Engineer position at our company offers a hybrid work flexibility model, which allows employees to balance their work from home with office presence. This model fosters both personal productivity and team collaboration in a supportive environment.

In responding to this question, consider sharing specific projects where you've implemented post-market surveillance strategies. Highlight how you ensured compliance with FDA and EU regulations, emphasizing any data-driven decisions made based on surveillance findings.

Use this opportunity to discuss your systematic approach to data collection and analysis. Explain which tools you use, such as Power BI or Excel, and provide examples of how your visualization of data has influenced key business decisions.

Be specific about your familiarity with these quality management standards. Discuss any auditing responsibilities you had, and how your adherence to these guidelines impacted product quality and compliance.

Illustrate your communication strategies, perhaps by discussing how you've utilized tools like Microsoft Project for team collaboration. Providing an example of a time when effective communication advanced a critical project will strengthen your answer.

Detail your proactive approach in managing quality issues, including the steps you would take to investigate, document, and communicate the findings to stakeholders, while ensuring compliance with regulatory requirements.

Explain the statistical tools you utilize in your work, including Minitab, and how you apply them in real-world scenarios to inform quality improvements or risk assessments related to product performance.

Choose a project where you led a team through a significant improvement initiative. Describe your leadership style and how you navigated challenges, highlighting measurable results that came from your efforts.

Discuss techniques you’ve used to motivate strong collaboration and commitment to change. Providing specific examples of how you fostered a positive attitude towards change among team members will demonstrate your leadership capability.

Share best practices you have adopted to stay up-to-date with regulatory changes and how you have implemented compliance strategies within your teams to proactively address challenges.

Elaborate on your ability to remain organized and focused amidst competing priorities. Referencing project management tools and methodologies you’ve utilized can show your strategic planning abilities.