Quality Engineer I - job 1 of 2

As a Quality Engineer I at Penumbra, you will focus on various responsibilities including providing input during the design control process, managing supplier quality, and ensuring adherence to the Quality Management System. You'll also identify opportunities for improving processes and determining the root causes of quality assurance issues for medical device production, playing a crucial role in enhancing product safety and efficacy.

To apply for the Quality Engineer I position at Penumbra, candidates must have a Bachelor's or Master's degree in an engineering or scientific discipline. Additionally, 1+ years of experience in a manufacturing or laboratory environment is preferred, along with strong written and oral communication skills and the ability to thrive in a fast-paced and collaborative work environment.

The work environment for a Quality Engineer I at Penumbra is primarily an office setting with occasional exposure to practical lab and manufacturing elements. You can expect a dynamic atmosphere that encourages collaboration and problem-solving, designed to propel innovative medical solutions while ensuring quality and compliance with regulations.

At Penumbra, Quality Engineers I are positioned for growth through continuous learning and exposure to various projects. There is a strong emphasis on teamwork and performance, allowing for advancement in career paths within quality engineering and related fields as you gain knowledge and experience over time.

Penumbra offers a comprehensive benefits package for Quality Engineer I positions, including medical, dental, vision, life and disability insurance, a 401(k) plan with employer matching, an employee stock purchase plan, paid parental leave, and generous vacation and sick time. These benefits reflect our commitment to supporting your personal and professional well-being.

Absolutely! A quality management system (QMS) is essential for ensuring that products meet regulatory and quality standards. As a Quality Engineer I, you'll utilize the QMS to maintain compliance, manage documentation, and oversee quality protocols throughout the product lifecycle.

To identify the root cause of a quality issue, I would implement techniques like the 5 Whys, Fishbone diagrams, and process mapping. Each of these methods helps drill down into the problem, ensuring we address the actual source rather than just the symptoms.

In tackling process improvements, I would start by evaluating current workflows using value-stream mapping to identify bottlenecks. Then, I'd engage team members for feedback and brainstorm solutions that align with both efficiency and quality goals, conducting trials and analyzing data to validate improvements.

When conflicts arise in a team, I believe clear communication is key. I would aim to facilitate open discussions, encouraging team members to express their perspectives while steering towards our common goal. Collaborative problem-solving often resolves issues and strengthens the team's dynamic.

I have worked closely with regulatory standards such as ISO and FDA requirements. Specifically, I've contributed to compliance documentation and quality audits, ensuring that products meet all necessary guidelines for safety and effectiveness in the healthcare sector.

Prioritizing tasks requires a structured approach. I typically assess project deadlines, the impact on patient safety, and compliance requirements. By collaborating with my team to align on priorities based on urgency and resource availability, I ensure that key projects stay on track.

I have practical experience in utilizing statistical analysis tools like SPC and Six Sigma methodologies to analyze quality metrics. These analyses guide my decisions on process optimizations, validate improvements, and ultimately enhance product quality and patient safety.

To ensure clear communication, I advocate for regular team meetings and cross-departmental collaborations where we can share updates, challenges, and successes. Using collaboration tools and ensuring documentation is accessible helps keep everyone informed and aligned in our quality efforts.

Certainly! In my previous role, I led a project aimed at reducing cycle times in product testing. By analyzing workflows and implementing lean principles, we achieved a 20% reduction in testing time while maintaining stringent quality standards, showcasing the effectiveness of process improvements.

Feedback is crucial in quality engineering. I embrace feedback as a means to iterate and improve processes. Listening to team insights and customer feedback allows for a more comprehensive understanding of quality standards, ensuring that the final product is aligned with user expectations.