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Quality Engineer - Plastic Manufacturing - Delta Mold LLC
Software Engineer
Quality Engineer specializing in plastic manufacturing, driving product compliance and performance through ISO 13485, FDA, HACCP, CGMP, and ISO 9001 standards while applying statistical process control and root‑cause analysis.
About the role
Key Responsibilities
- Develop, implement, and maintain quality management systems aligned with ISO 13485, ISO 9001, FDA, HACCP, and CGMP requirements.
- Conduct process audits, inspections, and validation activities to ensure product safety, compliance, and performance.
- Apply statistical process control and data‑driven analysis to monitor production metrics and identify improvement opportunities.
- Lead root‑cause investigations for non‑conformances, drive corrective and preventive actions, and track effectiveness.
- Collaborate with engineering, production, and supply‑chain teams to integrate quality standards into product design and manufacturing processes.
Requirements
- Bachelor’s degree in Engineering, Materials Science, or related field with 3+ years of quality engineering experience in plastic manufacturing.
- Hands‑on knowledge of ISO 13485, ISO 9001, FDA regulations, HACCP, and CGMP.
- Proficiency in statistical process control tools, FMEA, and root‑cause analysis methodologies.
- Strong problem‑solving skills, attention to detail, and ability to communicate technical findings to cross‑functional teams.
- Experience with continuous‑improvement frameworks such as Six Sigma or Lean manufacturing is preferred.