Quality Engineer
Medical Device Specialist
Key Responsibilities
• Develop and implement solutions to sustain and improve the quality management system (QMS).
• Maintain and support compliance to ISO standards.
• Interface with customers on new products, quality issues, and process qualifications.
• Develop and implement process control programs to ensure customer requirements are met.
• Perform process validations and qualification on products.
• Provide manufacturing support and quality expertise in relation to manufacturing issues and product disposition.
• Perform quality engineering analysis to identify strategies to prevent quality non-conformances and minimize risk.
• Coordinate non-conforming material/CAPA process to ensure timely resolution and closure of issues.
• Lead training activities on quality procedures, such as compliance, GMP, audit preparation, and GDP.
• Support and represent the site during external audits and conduct internal audits.
• Trend and track quality data to support quality improvements across the business.
• Support environmental, health, and safety requirements, training, and regulations.
Qualifications & Key Attributes
• Third-level qualification in engineering, polymer science, or equivalent manufacturing experience.
• Experience in statistical analysis, Minitab, SPC, and validations.
• Excellent interpersonal, communication, influencing, and facilitation skills.