manufacturing continuous improvement and development as the Quality team member for validation including IQ, OQ, PQ, and test method...
Validations (IQ/OQ/PQ) for product launch. Conduct Packaging Validations for new products. Develop and implement procedures... and executing IQ/OQ/PQ protocols. Knowledgeable in product lifecycle transitions and DFM principles. Proficiency in SolidWorks CAD...
(PQ) Validation Report Approval (VRA) Support advanced manufacturing engineering and sustainment engineering in the...
validation (IQ/OQ/PQ) and ensure compliance with FDA and ISO 13485 requirements. Partner cross-functionally with Quality...
Qualification (PQ) phases as required. Ensure compliance with applicable safety, environmental, and regulatory requirements...
during Prototyping, Engineering Evaluation, V&V, and PQ/PV. ADDITIONAL RESPONSIBILITIES: All other duties as assigned. EDUCATION...
without supervision. Work closely with Discovery and Engineering during Prototyping, Engineering Evaluation, V&V, and PQ/PV...
. Strong knowledge of PPAP, IQ/OQ/PQ, PFMEA, MSA, and control plans. Familiarity with FDA and ISO 13485 standards. Excellent...
, SDS, FS, validation plan, FAT, SAT, IQ, OQ,PQ, validation certificate, PIR,RTM, electronic signature, electronic reports...
during Prototyping, Engineering Evaluation, V&V, and PQ/PV. ADDITIONAL RESPONSIBILITIES: All other duties as assigned. EDUCATION...