What are the responsibilities and job description for the Senior Quality Engineer Molding position at SHL Medical?
Senior Quality Engineer – Molding
Location: Charleston, South Carolina, US
SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.
Job Overview
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.
Main Responsibilities
For more information on SHL Medical, please visit: shl-medical.com
Location: Charleston, South Carolina, US
SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.
Job Overview
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.
Main Responsibilities
- Lead and oversee all quality-related activities for injection molding processes, from techtransfer receiving to mass production.
- Collaborate with engineering, tooling, QC, QA, and production teams to ensure sufficient controls for mass production components to meet defined quality requirements.
- 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.
- Maintain Process-FMEA (PFMEA) and control plans to proactively identify and mitigate risks.
- Drive root cause analysis and CAPA implementation for quality issues, ensuring effective containment, correction, and prevention.
- Ensure proper documentation and traceability in accordance with internal procedures and regulatory requirements.
- Provide mentorship and technical guidance to quality engineers, technicians, and cross-functional team members
- Support internal, supplier, and customer audits as the molding process quality subject matter expert (SME).
- 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.
- Competitive compensation package
- Modern working environment with state-of-the-art facilities and technologies
- Challenging assignments in a fast growing and innovative industry
- Position in a dynamic, international team of highly skilled professionals
- Various opportunities for personal and professional development within a global organization
For more information on SHL Medical, please visit: shl-medical.com