Quality Engineer II

Job Summary

The Quality Engineer II plays a key role in ensuring product and process quality throughout the product lifecycle. This position involves applying quality engineering principles to prevent defects, improve manufacturing processes, and maintain compliance with established standards.

Job Responsibilities

• Develop, implement, and maintain quality control plans and procedures for new and existing products.

• Conduct root cause analysis for product non-conformances and process deviations, implementing effective corrective and preventive actions (CAPA).

• Perform statistical analysis of quality data to identify trends, opportunities for improvement, and risks.

• Participate in design reviews, process validations, and manufacturing readiness reviews to ensure quality requirements are met.

• Collaborate with cross-functional teams (e.g., R&D, Manufacturing, Supply Chain) to integrate quality into product development and production.

• Support internal and external audits, ensuring compliance with ISO standards, customer specifications, and regulatory requirements.

• Develop and deliver quality training to manufacturing personnel and other stakeholders.

• Review and approve engineering changes, ensuring their impact on product quality is assessed and controlled.

• Drive continuous improvement initiatives using methodologies such as Six Sigma, Lean Manufacturing, and FMEA.

• Document and report on key quality metrics and performance indicators.

Job Qualifications

• Bachelor's degree in Engineering (e.g., Mechanical, Electrical, Industrial, Manufacturing) or a related technical field.

• 3-5 years of experience in a Quality Engineering role within a manufacturing environment.

• Strong understanding of quality management systems (e.g., ISO 9001, AS9100, ISO 13485 depending on industry).

• Proficiency in statistical process control (SPC), measurement system analysis (MSA), and other quality tools.

• Demonstrated experience with root cause analysis methodologies (e.g., 8D, 5 Why, Fishbone diagrams).

• Excellent analytical, problem-solving, and decision-making skills.

• Strong communication and interpersonal skills, with the ability to effectively collaborate with diverse teams.

• Ability to read and interpret technical drawings and specifications.

• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).

• ASQ certifications (e.g., CQE, CSSBB) are a plus.