We are seeking a detail-oriented and proactive Quality Engineer with strong experience in injection molding and Test Method Validation (TMV). The ideal candidate will be responsible for ensuring product quality through process validation, root cause analysis, and the development and implementation of quality control systems. This role supports continuous improvement efforts and works closely with manufacturing, engineering, and quality teams to ensure products meet or exceed customer expectations and regulatory requirements.

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Key Responsibilities:

• Lead and support quality assurance activities for injection molding processes.
• Conduct and document Test Method Validations (TMVs) according to regulatory and internal requirements.
• Develop and execute process validations (IQ/OQ/PQ) for new and existing molding tools and processes.
• Monitor, analyze, and report on process capability (Cp, Cpk) and implement corrective actions where necessary.
• Perform root cause analysis (RCA) and lead implementation of Corrective and Preventive Actions (CAPA).
• Collaborate with cross-functional teams (Manufacturing, R&D, Tooling, etc.) during product development and launch phases.
• Create and maintain Quality Inspection Plans, FMEAs, Control Plans, and PPAP documentation.
• Support internal and external audits  
• Ensure compliance with industry standards and customer requirements.
• Utilize statistical tools for data analysis and decision-making (SPC, MSA, DOE).
• Participate in continuous improvement initiatives, including lean manufacturing and Six Sigma activities.

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Qualifications:

• Bachelor’s degree in Engineering, Quality, or related field.
• 3+ years of quality engineering experience in a manufacturing environment, preferably in injection molding.
• Strong knowledge of Test Method Validation (TMV) and process validation.
• Experience with GD&T, blueprint reading, and inspection techniques.
• Familiarity with relevant quality standards.
• Proficiency in quality tools such as FMEA, SPC, MSA, DOE, 8D, CAPA, etc.
• Strong problem-solving and analytical skills.
• Excellent communication and documentation skills.
• Certification such as CQE, Six Sigma Green/Black Belt, or similar is a plus.

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Preferred Skills:

• Hands-on experience with molding machines and tooling validation.
• Knowledge of medical device regulations (if applicable).
• Experience with statistical software (e.g., Minitab).