Principal Quality Engineer

As a Principal Quality Engineer at Medtronic, your responsibilities will include the development and maintenance of quality standards for biomedical and medical device manufacturing. You'll collaborate with engineering teams, implement inspection and testing methods, and ensure compliance with FDA regulations. Additionally, you'll coordinate quality protocols like IQ, OQ, and PQ, utilize ERP systems for quality management, and drive process improvements through statistical analysis.

To qualify for the Principal Quality Engineer position at Medtronic, you need at least a Master’s degree in Mechanical, Industrial, or Biomedical Engineering. A minimum of five years of relevant experience is required, particularly in the biomedical industry, with hands-on familiarity with FDA Quality System Regulations and various quality assurance methodologies like CAPA and FMEA.

Principal Quality Engineers at Medtronic frequently use quality management software like TrackWise, along with ERP systems such as ProShop and SAP. Proficiency in data analysis tools like Minitab or JMP is also essential for this role, as they help interpret data for process improvement and validation activities.

Medtronic is committed to the professional growth of its employees, including Principal Quality Engineers. The company offers various educational benefits such as tuition assistance, reimbursement programs, and access to global well-being initiatives. This ensures that you can continue to learn and advance in your career while contributing to innovative projects.

The work culture for a Principal Quality Engineer at Medtronic in Billerica is collaborative and innovative. You will be part of a diverse team that values high standards and shared goals in producing safe and effective medical devices. The company promotes a supportive environment, encouraging open communication, teamwork, and professional development.

When discussing your experience with FDA Quality System Regulations during the interview, provide specific examples of how you ensured compliance in past roles. Highlight any systems you have implemented or their impact on product quality and safety.

Articulate your familiarity with quality assurance methodologies such as CAPA, FMEA, and SPC. Give specific examples of how you have applied these concepts in practical situations, showcasing your problem-solving skills and proactive approach.

To answer this question, you should emphasize your process for evaluating existing practices, identifying gaps, and designing standards that meet regulatory requirements. Discuss your collaborative approach in engaging with manufacturing and engineering teams to ensure buy-in.

When answering this question, provide a clear narrative outlining the problem, steps taken for root cause analysis, implemented solutions, and results. This will showcase your analytical abilities and initiative in addressing quality issues.

Highlight your proficiency in Minitab or JMP, including specific types of analysis you have conducted (e.g., regression analysis, control charts). Discuss how your findings influenced decision-making and improved product quality or processes.

Detail your systematic approach for CAPA, including identifying non-conformances, documenting findings, and following through with preventative measures. Emphasize your ability to track and report on these actions using software like TrackWise.

Discuss various testing techniques you employ, such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Provide examples of how these techniques ensured quality and safety standards were met in previous projects.

Mention your proactive strategies for staying updated on regulatory changes, such as attending workshops, webinars, or industry conferences. Discuss how you integrate this knowledge into your work to ensure compliance and quality.

Focus on your ability to communicate effectively and build relationships with other departments like engineering, production, and R&D. Explain how cross-department collaboration can lead to innovative solutions and enhanced quality merchandise.

Be genuine in your response. Share your passion for improving healthcare outcomes through quality assurance, emphasizing any personal experiences or motivations that drive you in creating safe, effective medical devices.