Compliance Engineer IV

As a Compliance Engineer IV at KARL STORZ, your responsibilities include overseeing global component planning, establishing compliance standards, and addressing complex vendor issues. You will collaborate with engineering teams to analyze components and ensure adherence to various regulations, including China RoHS and REACH. Another vital part of your role includes monthly reviews of the global parts library and offering training sessions about compliance standards within the organization.

To be considered for the Compliance Engineer IV position at KARL STORZ, you should have a Bachelor’s degree in Mechanical, Electrical, or Software Engineering, along with a minimum of 10 years of experience in component engineering. Additionally, you'll need at least 8 years of experience in the medical device field. Knowledge of FDA Quality System Regulation and ISO standards is crucial to excel in this role.

In the role of Compliance Engineer IV at KARL STORZ, you will be actively involved in collaboration with other engineering teams. This collaboration will involve analyzing components, setting specifications, and pursuing cost-reduction initiatives. You will also play an integral part in product development teams, ensuring thorough management of Design History Files and compliance with both FDA and ISO regulations.

Having experience with FDA Quality System Regulation (21 CFR Part 820) and ISO standards (13485, 9001) is immensely significant for a Compliance Engineer IV at KARL STORZ, as it ensures you understand the regulatory landscape of medical devices. This knowledge is vital for maintaining compliance while working on cutting-edge medical technology and contributes to the overall success of the company's projects.

A Compliance Engineer IV at KARL STORZ plays a pivotal role in ensuring that all medical devices meet stringent regulatory requirements. By managing compliance-related tasks, overseeing audits, and providing training, you contribute directly to the quality and safety of medical technologies that impact patients and healthcare providers alike. Your work helps foster innovation while adhering to necessary legal standards.

When addressing your experience with FDA quality regulations, be specific about the projects you've worked on. Detail how you ensured compliance during product development and any inspection experiences you've had. Highlight your understanding of 21 CFR Part 820, and provide examples of how you contributed to meeting these regulatory requirements.

To stay current with compliance standards, you can mention subscribing to industry newsletters, participating in continuing education courses, and attending relevant workshops or conferences. Discuss how you leverage this knowledge in your roles to ensure that all projects are compliant with the latest regulations.

Share a concrete example of a compliance issue you've faced, explaining the situation, your actions, and the results. It's important to illustrate your problem-solving skills and ability to navigate complex compliance landscapes while working at KARL STORZ.

Discuss your methods for prioritizing tasks such as using project management tools or maintaining a task list. Emphasize your ability to balance compliance duties with project deadlines, ensuring that regulatory aspects are never compromised.

In answering this, detail your auditing processes, such as how often you conduct audits, the metrics you monitor, and how you document findings. Highlight your ability to identify areas of improvement and implement new best practices at KARL STORZ.

Your response can focus on collaboration techniques such as holding regular meetings, encouraging open communication, and providing training sessions to educate other engineers about compliance standards. Mention your experience in teamwork and fostering a cooperative compliance culture.

Discuss specific instances where you managed component replacements effectively. Talk about your role in assessing alternatives, ensuring compliance, and coordinating efforts with suppliers and teams to implement the changes swiftly.

Share details about the training session you conducted, including the audience, topics covered, and feedback received. Highlight your approach in simplifying complex compliance topics to enhance understanding at KARL STORZ.

Emphasize the critical nature of teamwork in achieving compliance. Share how you foster collaboration among various departments and the positive impact it has on meeting compliance goals while also contributing to innovative product development.

Illustrate a methodical approach: identify the issue, investigate, determine root causes, and implement corrective actions with timelines. Stress the importance of communication and providing updates to stakeholders at KARL STORZ to ensure transparency throughout the process.