Position Details
Quality Engineer Apply
Poistion- Quality Engineer
Location: Ponce, Puerto Rico
Job description
Job description
- Collaborate on DFM/DFA activities to optimize packaging and production processes.
- Support manufacturing, validation, and qualification activities (IQ, OQ, PQ, MSA).
- Conduct root cause analysis (RCA), NCR, and CAPA responses.
- Lead validation, PFMEA, and statistical analysis (SPC, DOE).
- Drive process improvements and troubleshoot production issues.
- Execute Site Acceptance Tests (SAT) and Factory Acceptance Tests (FAT).
- BS in Mechanical Engineering or equivalent (MS preferred)
- 3+ years of experience in packaging engineering, medical devices, or related industries.
- Strong expertise in validation, process optimization, and quality systems.
