Quality Engineer II (Goleta, CA)

As a Quality Engineer II at KARL STORZ, your main responsibilities include developing and implementing quality systems and processes, collaborating with teams to identify and mitigate quality risks, analyzing quality data for improvement trends, providing training to staff to foster a culture of quality, and representing the company during external audits and inspections. Your role is essential in maintaining high-quality standards for our medical devices.

To qualify for the Quality Engineer II role at KARL STORZ, candidates need a BS degree in a technical or engineering discipline along with at least 3 years of experience in a manufacturing setting. A strong understanding of ISO 13485 and FDA/QSR regulations is crucial, alongside excellent communication and problem-solving skills. Preferred qualifications include CQE certification, experience with Six Sigma and Lean manufacturing, and a background in the medical device industry.

Important skills for the Quality Engineer II position at KARL STORZ include proficiency in statistical software systems like Minitab or SPSS, strong measurement system analysis skills, and the ability to create sampling plans. Familiarity with ERP systems like SAP and Microsoft Office tools, especially Excel, is also important as these tools are used for data analysis and reporting.

At KARL STORZ, we value the growth of our employees and offer various professional development opportunities for Quality Engineer II staff. These include access to training programs, workshops, and seminars that enhance technical skills, as well as a supportive environment that encourages innovative ideas and continuous improvement. We believe in nurturing talent to help you achieve your career goals.

The Quality Engineer II position is crucial to KARL STORZ's mission of delivering the highest quality medical devices that significantly impact patient outcomes. By ensuring compliance with regulatory standards and driving quality improvements, you play a key role in maintaining our reputation for excellence and innovation within the healthcare industry.

In answering this question, detail specific quality systems you've worked with, such as ISO 13485, and share examples of how you contributed to their implementation or improvement. Highlight any collaborations with cross-functional teams to show your ability to work well with others.

Discuss the statistical software tools you are proficient in, such as Minitab, and describe your analytical approach. Provide examples of how you've used data analysis to identify trends and implement corrective actions in previous positions.

Explain your methodology for addressing non-conformities, including root cause analysis and corrective action plans. Provide a concise example where you successfully resolved an issue and improved the process to prevent recurrence.

Share your experience in creating training programs or workshops. Highlight your approach to ensuring that training is engaging and effective, as well as any feedback you’ve received from participants to demonstrate your success.

Discuss your strategies for keeping updated, such as attending workshops, reading professional journals, or being part of industry groups. This demonstrates your commitment to ongoing learning and adherence to regulations.

Provide a detailed example of a quality improvement project, including your specific role, strategies employed, and measurable outcomes. This will illustrate your ability to lead and positively impact the quality standards.

Share your experience during an audit, focusing on how you prepared, the outcome, and how you addressed any issues raised by the auditors. Highlight your ability to communicate effectively under pressure.

Be honest and provide insights into challenges such as balancing compliance with innovation. Discuss how you navigate these challenges, emphasizing your problem-solving skills and adaptability.

Discuss the importance of statistical methods in identifying trends, improving processes, and ensuring product quality. Provide examples of how you’ve applied statistical analysis to real-world quality engineering challenges.

Share your passion for quality engineering and how it aligns with KARL STORZ's mission in the MedTech industry. Highlight your desire to work with cutting-edge technologies and contribute to improving patient outcomes.