1. GENERAL INFORMATION
Job title Senior Quality Engineer Molding
Function / Department Quality Engineering
Career Band / Global
Grade/Exemption Status Non-Exempt
Reporting to (Title) Quality Engineering Manager
Location / Country Charleston, SC / US
Effective date
2. JOB OVERVIEW / PURPOSE
The Lead Molding Quality Engineer is responsible for ensuring the quality and robustness of injection molding processes and all supporting processes used in the manufacture of medical devices and components. The role need to ensure risk assessment and risk mitigations of new tool, all supporting processes, and master batch process. Review and define validation strategy so it represents mass production. Working closely with Manufacturing Engineering, Operational Engineering, and Quality Assurance, the Lead Molding Quality Engineer develops and sustains process control strategies, leads root cause investigations, and ensures compliance with ISO 13485, FDA 21 CFR 820.
3. MAIN RESPONSIBILITIES
The Senior Quality Engineer Molding has responsibilities to: 1. Lead and oversee all quality-related activities for injection molding processes, from techtransfer receiving to mass production. 2. Collaborate with engineering, tooling, QC, QA, and production teams to ensure sufficient controls for mass production components to meet defined quality requirements. 3. Review and improve Process Validation (IQ/OQ/PQ) for end-to-end molding process and ensure all activities comply with regulatory, QMS requirements, and mass production needs. 4. Maintain Process-FMEA (PFMEA) and control plans to proactively identify and mitigate risks. 5. Drive root cause analysis and CAPA implementation for quality issues, ensuring effective containment, correction, and prevention. 6. Ensure proper documentation and traceability in accordance with internal procedures and regulatory requirements. 7. Provide mentorship and technical guidance to quality engineers, technicians, and cross-functional team members. 8. Support internal, supplier, and customer audits as the molding process quality subject matter expert (SME).
4. PROFILE
Competencies, skills, knowledge & qualifications needed to fulfill the position. 4.1. Relevant Qualification: (education and training) Required: " Bachelor's degree or above in Mechanical, Manufacturing, Polymer, or related Engineering field. " 5+ years of experience in Quality or Manufacturing Engineering, with at least 3 years focused on injection molding in a regulated industry (medical device preferred). " Deep understanding of injection molding processes, tooling design, polymer materials, and process optimization. " Strong knowledge of regulatory and quality system requirements (ISO 13485, ISO 14971, FDA 21 CFR 820, GMP). " Skilled in statistical analysis and quality tools such as Minitab, SPC, DOE, and FMEA. " Proven experience in process validation, metrology, and dimensional analysis. " Excellent communication and leadership skills with ability to influence cross-functional teams. " Green Belt or Black Belt certification preferred. 4.2. Language skills Mandatory (Must) " English