Job Title: Quality Engineer
Location: Raleigh, North Carolina
Job Type: 24+ Months
Department: Engineering
Job Description
We are seeking a highly skilled
Quality Engineer to join our team. The Quality Engineer will be responsible for ensuring that products meet all quality standards and regulatory requirements throughout the development and manufacturing process. The ideal candidate will have a strong technical background, experience in quality control, and a keen attention to detail. This role requires a proactive approach to problem-solving and continuous improvement to enhance product quality and performance.
Key Responsibilities
- Quality Assurance: Develop, implement, and maintain quality standards, procedures, and systems to ensure product compliance with internal and external requirements.
- Inspection and Testing: Perform inspections and tests on products and materials to verify compliance with specifications and industry standards.
- Root Cause Analysis: Investigate quality issues, identify root causes, and implement corrective and preventive actions (CAPA).
- Documentation: Create and maintain detailed reports, documentation, and quality records to track quality performance and ensure traceability.
- Continuous Improvement: Drive continuous improvement initiatives to enhance product quality, reduce defects, and improve efficiency.
- Supplier Quality Management: Collaborate with suppliers to establish quality requirements, conduct audits, and ensure the delivery of high-quality materials.
- Compliance: Ensure adherence to industry regulations, including ISO standards, FDA regulations, and other relevant quality standards.
- Cross-Functional Collaboration: Work closely with production, design, and engineering teams to address quality concerns and implement solutions.
Required Qualifications
- Bachelor’s degree in Engineering, Quality Assurance, or a related field.
- 3+ years of experience in quality engineering or quality assurance in a manufacturing environment.
- Strong understanding of quality systems, statistical analysis, and process control methodologies.
- Proficiency in quality tools such as Six Sigma, Lean Manufacturing, FMEA, and SPC.
- Experience with ISO standards and regulatory compliance ISO 9001 or ISO 13485
- Excellent problem-solving skills with a focus on root cause analysis and corrective actions.
- Strong communication skills and ability to work collaboratively across departments.
Preferred Qualifications
- Certified Quality Engineer (CQE) or Six Sigma certification.
- Experience in highly regulated industries such as medical devices, aerospace, or automotive.
- Experience with supplier quality management and auditing.