Job Description

Experience : 8–10 years minimum

Job Summary

Seeking an experienced Quality Engineer to support medical device manufacturing through validation, process improvement, and compliance activities. The ideal candidate will have a strong background in quality systems, validation (IQ/OQ/PQ), root cause analysis, and cross-functional collaboration.

Key Responsibilities

• Drive quality improvements in product cost, process, and compliance.
• Support DFM/DFA activities and manufacturing validations (IQ, OQ, PQ, MSA).
• Conduct RCA, NCR, CAPA and execute process improvements.
• Lead equipment and process testing, validation, and PFMEA.
• Apply statistical tools (SPC, SQC, DOE) for quality assurance.
• Manage CDPs, SAT/FAT, and validation gap analyses.
• Collaborate with cross-functional teams on production floor troubleshooting.
• Support documentation, process updates, and material disposition.

Qualifications

• BS in Packaging Science, Mechanical, or equivalent Engineering.
• 8 years in packaging/quality engineering in medical devices or pharma.
• Strong knowledge of validation, quality systems, and manufacturing processes.

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