Quality Engineer

Quality Engineer

Apply quality engineering initiatives from concept through production to ensure robust design, efficient processes, and consistent product performance. Ensure product and process quality by applying structured problem-solving methodologies across departments, fostering cross-functional collaboration. Drive continuous improvement initiatives to minimize process variation, scrap, and Cost of Poor Quality (COPQ) through proactive analysis and lean principles. Utilize data-driven root cause analysis to implement effective corrective and preventive actions that enhance long-term product and process reliability.

Key Responsibilities

• Apply quality engineering initiatives from concept through production to ensure robust design, efficient processes, and consistent product performance.
• Ensure product and process quality by applying structured problem-solving methodologies across departments, fostering cross-functional collaboration.
• Serve as a key technical liaison with customers to address quality concerns, manage complaint resolution, and ensure timely, data-driven responses to issues affecting product performance or compliance.
• Lead and support continuous improvement initiatives using structured methodologies such as Lean, Six Sigma, DFSS, and Shainin LLC Technical problem solving to reduce variation and enhance product and process capability.
• Develop a strong working knowledge of precision measurement equipment (e.g., CMMs, vision systems, etc.) to provide technical guidance, support troubleshooting, and train QC Inspectors in proper operation, programming and best practice.
• Direct, design and develop custom mechanical or electromechanical fixtures, gauges, and tools to streamline inspection processes and enable effective use by QC technicians and/or shop floor operators.

Required Qualifications

• BSME Bachelor of Science Degree in Mechanical Engineering preferred.
• Bachelor of Science degree in physical science, engineering, or a closely related technical discipline that emphasizes analytical thinking, design principles, and structured problem solving.
• 7-10 years of industry experience with a minimum of 3-5 years of QE experience in structured root cause analysis and problem solving, ideally within the medical device components industry or a similarly regulated manufacturing environment.

Preferred Qualifications

• Lean/Six Sigma Black Belt certification, CQE, a plus.
• Experience with ISO 13485:2016 a plus.
• Proficient in statistical analysis tools and techniques; experience with Minitab, SPC methods.
• Ideal candidate demonstrates knowledge and is a practitioner of Lean Manufacturing, Six Sigma, Design for Six Sigma (DFSS) methodologies, Shainin LLC Technical Problem Solving or similar root cause analysis methods.
• Familiarity with injection molding processes is a plus.
• Proficiency in SolidWorks, with demonstrated ability to design fixtures, inspection tooling, and quality-related mechanical components; strong mechanical aptitude and understanding of mechanisms is essential.
• Experience with other CAD platforms is acceptable with a willingness and ability to transition to SolidWorks.
• Proficiency in Microsoft Excel for data analysis, reporting, and visualization