(Sr.) Quality Engineer Molding

SHL Medical • Charleston, SC

1d

About The Position

The 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 tools, all supporting processes. Review and define validation strategy so it represents mass production.

Requirements

• Bachelors degree or above in Mechanical, Manufacturing, Polymer, or related Engineering field.
• 3+ 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 skills with ability to influence cross-functional teams.

Nice To Haves

• Green Belt or Black Belt certification preferred.

Responsibilities

• 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.
• Responsible for localizing the received P-FMEA to ensure local risks are captured and mitigated properly before handing the equipment to mass production.
• Collaborate with cross-functional teams (Process Development, Operation Engineering, Manufacturing, QA, QC) during Tech Transfer Receiving to ensure robust process controls, representative tool validation, and smooth transitions to mass production.
• Ensure proper documentation and traceability in accordance with internal procedures and regulatory requirements.
• Support QA in root-cause investigations and implement effective Corrective and Preventive Actions (CAPA) to address process non-conformities related to assembly process
• Support internal, supplier, and customer audits as the molding process quality subject matter expert (SME).

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level