The RoleWe're seeking a Sr. Quality Engineer to play a critical role in advancing product quality, ensuring regulatory compliance, and driving process improvements across our manufacturing operations.
If you're passionate about root cause analysis, quality systems, statistical analysis, and leading impactful improvement initiatives, this could be the perfect opportunity for you.
What You'll Do:- Lead quality improvement initiatives focused on reducing product escapes, improving yields, and enhancing customer satisfaction.
- Develop, implement, and monitor quality metrics to evaluate process effectiveness and identify improvement opportunities.
- Conduct internal audits, process audits, verification and validation activities, and compliance assessments.
- Support and maintain ISO 9001, ISO 13485, and applicable regulatory quality system requirements.
- Drive root cause investigations, corrective actions, and preventive actions (CAPA).
- Perform process capability studies, statistical analysis, and trend reporting to support data-driven decision-making.
- Design and execute product verification and validation test plans.
- Collaborate with Engineering, Manufacturing, and New Product Development teams to improve product quality and reliability.
- Mentor Quality Engineers and represent the Quality department in cross-functional meetings.
- Support customers and technical teams in resolving product quality concerns and field issues.
What You'll Bring:- Bachelor's degree in Engineering or a related technical field.
- 5-7 years of experience in quality engineering, manufacturing, product development, or quality systems.
- Experience working within ISO 9001, ISO 13485, FDA QMSR, or similar regulated environments.
- Strong understanding of quality tools, root cause analysis, CAPA, verification and validation, and process controls.
- Experience with statistical analysis and process capability studies.
- Proficiency in Microsoft Office applications, including Excel and PowerPoint.
- Strong communication, collaboration, and problem-solving skills.
Preferred Qualifications:- ASQ certifications such as CQE, CQT, CCT, or CRE.
- Experience with Minitab or similar statistical software.
- Knowledge of electronic products, manufacturing processes, and quality systems.
- Experience supporting regulated manufacturing environments.
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