Senior Quality Engineer

Job Description

Job Description

Job Summary

We are seeking a highly skilled and experienced Senior Quality Engineer to join our dynamic manufacturing team. The Senior Quality Engineer will lead quality assurance initiatives, oversee quality control processes, and ensure compliance with industry standards and regulations. This pivotal role involves developing, implementing, and maintaining robust quality systems to enhance product reliability, safety, and customer satisfaction. The ideal candidate will possess strong analysis skills, project management capabilities, and a comprehensive understanding of quality management principles across manufacturing environments.

Duties

• Develop, implement, and maintain comprehensive quality management systems aligned with ISO 13485, ISO 9001, FDA regulations, HACCP, and CGMP standards.
• Lead quality audits internally and externally to ensure compliance with regulatory requirements and industry best practices.
• Oversee quality control procedures, including inspections and testing of raw materials, in-process components, and finished products to ensure adherence to specifications.
• Collaborate with cross-functional teams to identify root causes of quality issues and implement corrective and preventive actions (CAPA).
• Conduct detailed analysis of quality data to monitor trends, identify areas for improvement, and support continuous process enhancement.
• Manage documentation related to quality assurance activities, audit reports, non-conformance reports, and validation protocols.
• Facilitate training sessions on quality standards and procedures for staff involved in manufacturing and quality inspection.
• Support new product development projects by integrating quality assurance measures from design through production.
• Coordinate with suppliers to ensure incoming materials meet specified quality standards.
• Lead efforts in maintaining compliance with regulatory bodies such as FDA and international standards.

Experience

• Proven experience as a Quality Engineer or similar role within a manufacturing environment.
• Extensive knowledge of ISO 13485 (medical devices), ISO 9001 (quality management systems), FDA regulations, HACCP principles, and CGMP guidelines.
• Demonstrated experience conducting quality audits and implementing effective corrective actions.
• Strong background in quality control techniques including inspection and testing methodologies.
• Familiarity with Quality Systems such as QA/QC processes, documentation control, and validation protocols.
• Excellent project management skills with the ability to lead multiple initiatives simultaneously.
• Analytical skills capable of interpreting complex data sets to inform decision-making.
• Prior experience in the development or oversight of manufacturing processes is highly desirable.

Benefits:

• Health insurance

Work Location: In person

Great work environment

Company Description

Great work environment