Quality Engineer

About the role:

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;