JOB OVERVIEW

We are seeking a dedicated and detail-oriented Quality Engineer to join our team. The ideal candidate will play a crucial role in ensuring that our products meet the highest quality standards and comply with relevant regulations. This position requires expertise in quality management systems and a strong understanding of industry standards such as ISO 13485, FDA regulations, and CGMP. The Quality Engineer will collaborate with cross-functional teams to drive continuous improvement initiatives and maintain compliance throughout the manufacturing process.

QUALIFICATIONS

• Bachelor’s degree in Engineering, Quality Assurance, or a related field is preferred.
• Proven experience in a quality engineering role within a manufacturing environment.
• Strong knowledge of ISO 13485, FDA regulations, HACCP, CGMP, and ISO 9001 standards.
• Experience conducting quality audits and implementing corrective actions based on findings.
• Proficiency in quality control methods, inspection techniques, and statistical analysis skills.
• Familiarity with QA/QC processes and project management principles is highly desirable.
• Excellent analytical skills with the ability to interpret complex data sets effectively.
• Strong communication skills with the ability to work collaboratively across departments. Join our team as a Quality Engineer where you can contribute to maintaining high-quality standards while ensuring compliance within our manufacturing processes!
  Job Type: Full-time
  Pay: $75,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Work Location: In perso

• Develop, implement, and maintain quality management systems in accordance with ISO 9001 and ISO 13485 standards.
• Conduct quality audits to ensure compliance with FDA regulations and HACCP guidelines.
• Perform quality inspections and control processes to identify defects or non-conformities in products.
• Collaborate with manufacturing teams to resolve quality issues and implement corrective actions.
• Lead projects focused on improving product quality through analysis and data-driven decision-making.
• Maintain documentation related to quality systems, including procedures, work instructions, and reports.
• Provide training and guidance on quality assurance practices to team members.
• Analyze data related to product performance and quality metrics to drive continuous improvement efforts.