Our client in Marlboro, MA is looking to bring on a Quality Engineering. Our client is looking for candidate who have experience working in a medical device environment. This is a direct hire opportunity.

QUALIFICATIONS

• Bachelor’s degree in Engineering or a related field is preferred.
• 5+ years of experience working as a Quality Engineer
• Proven experience in quality engineering within a manufacturing environment.
• Strong knowledge of ISO 13485, FDA regulations, HACCP, CGMP, ISO 9001, and other relevant quality standards.
• Experience conducting quality audits and familiarity with QA/QC processes.
• Excellent analytical skills with the ability to interpret complex data sets effectively.
• Strong problem-solving abilities and attention to detail in all aspects of work.
  Job Type: Full-time
  Pay: $80,801.43 - $97,309.25 per year
  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, CGMP, HACCP, and other relevant industry standards.
• Perform quality control inspections and assessments throughout the manufacturing process to identify defects or areas for improvement.
• Collaborate with cross-functional teams to analyze data and implement corrective actions for non-conformities.
• Lead projects aimed at enhancing product quality and operational efficiency through effective project management techniques.
• Prepare detailed reports on quality metrics, audit findings, and improvement initiatives for management review.