Quality Engineer I/II - Manufacturing

The Quality Engineer I/II supports Applied Medical’s Quality System by enhancing manufacturing and quality processes across a broad range of medical device technologies. This position plays a key role in ensuring the safety, performance, and reliability of products such as the Kii® access device and other minimally invasive surgical solutions. The Quality Engineer partners with cross‑functional engineering teams to strengthen product quality, maintain regulatory compliance, and drive continuous improvement within medical device development.

This role is well suited for individuals interested in quality engineering, medical device engineering, product development engineering, and manufacturing quality assurance.

Key Responsibilities:

• Maintain and improve elements of the Quality Management System by identifying opportunities to enhance process efficiency and compliance.
• Monitor quality metrics and trends and lead the preparation and presentation of insights and recommendations during management reviews.
• Develop and revise process control documentation, including work instructions, control plans, test methods, and graphical aids.
• Perform statistical analysis to support product verification, process control, and continuous improvement initiatives.
• Troubleshoot equipment, process, and product issues and collaborate with engineering teams to implement effective corrective actions.
• Participate in and assess investigations related to customer complaints, Non‑Conformance Reports, and supplier quality documentation.
• Provide quality engineering guidance on inspection methods, measurement system analysis, and the use of quality assurance tools.
• Contribute to product and process development activities, including risk analysis, validation planning, product testing, equipment and process validation, and design transfer to manufacturing.

Success in This Role Looks Like

• Driving process and product improvements that enhance product reliability and strengthen long‑term quality performance.
• Delivering clear, accurate, and compliant technical documentation that supports audits, regulatory submissions, and cross‑functional engineering efforts.
• Providing proactive data‑driven insights that influence decision‑making, guide corrective actions, and support management review processes.
• Leading cross‑functional initiatives that advance product innovation, ensure regulatory compliance, and improve manufacturing efficiency.
• Collaborating effectively with engineering, manufacturing, and quality assurance teams to resolve issues and maintain a high standard of operational excellence.

• Bachelor’s degree in engineering, science, or a Science, Technology, Engineering, and Mathematics field, or related education and experience (including BS in mechanical engineering or other engineering disciplines).
• Demonstrated ability to multitask, prioritize work, and manage time effectively in a dynamic environment.
• Strong technical, written, and verbal communication skills with the ability to prepare clear documentation and reports.
• Knowledgeable in product development, process optimization, risk analysis, continuous improvement, and verification and validation practices.
• Experienced in statistical process monitoring and data analysis software, including the ability to conduct product testing and apply technical documentation.
• Proficient in Microsoft Office applications, including Word, Excel, PowerPoint, and Outlook.
• Up to five years of experience in the medical device or manufacturing industry, including internships, co‑ops, or engineering project experience.
• Experience using project management tools such as Microsoft Project.
• Working knowledge of statistics related to verification testing, process control, and statistical analysis software such as Minitab.
• Understanding of manufacturing quality and risk management standards, including ISO 9001 and ISO/IEC 17025, with the ability to interpret and apply relevant regulations.

• American Society for Quality certifications, including Six Sigma, Certified Quality Auditor, or Certified Quality Engineer.
• Experience with medical device quality systems, including ISO 13485, quality assurance methodologies, and continuous improvement practices.
• Knowledge of Lean Six Sigma principles and other process improvement frameworks.
• Familiarity with root cause analysis methods, Design of Experiments, and advanced statistical techniques.
• Background in clinical or technical writing supporting regulatory documentation, validation reports, and process development records.