Quality Engineer at Innova Medical Group

Develop and implement quality control standards procedures and processes; drive continual improvement activities to enhance product and process quality; determine corrective actions through CAPA, NCMR, SCAR and complaint systems; perform root cause analysis and implementation of corrective action for product and process related issues; assist in capturing the quality objective, failure points and reject / scrap reporting; preparation of quality reports related to products and processes based on company and customer requirements; ensure that workflows, processes and products comply with safety regulations; conduct audits (internal/external) related to product and processes.

Sr. Quality Engineer at Axonics, Inc

Responsible for Charge System, Patient Remote and Trial Stimulator product lines; Maintained four product lines meeting all established metrics including: closing all customer complaints with 60 days; closing all NCMRs within 120 days; closing all CAPAs within 90 days; coordinated investigation and closure of CAPA, NCMR’s and complaints; performed Supplier Quality Audits and remediation of audit non-conformances; quality representative for implementation of MES (Manufacturing Electronic System) for paperless batch records and travelers; provided product line support to comply with 21 CFR 820, ISO 13485:2016 and EU MDR.

Quality Manager at Custom Chemical Formulators, Inc

Lead FDA 483 corrective actions and compliance; develop and implement document control system, including Quality Manual, Quality Statement, numbering system, standard document templates and approval system; develop and implemented Customer complaint, Non-conforming material process, Corrective and Preventive action (CAPA) and Supplier Management systems; manage Quality Control chemist group for timely lot releases; Next generation product transfer to manufacturing.

Quality Engineering Specialist at BBraun Medical

Led investigations and facilitate closure of CAPA and DSMS; reduced and maintained over 45 days open discrepancy records to zero for assigned product line; chaired cross functional root cause analysis team and MRB meetings for Duplex, CFM, PAB, Glass, E3 and PIC product lines; evaluated product/material discrepancies and implement corrective actions for PIRs; developed protocols for investigational study of questionable products; developed/executed training of Process Control associates for technical/investigation writing.

Principal Quality Engineer at Direct Flow Medical

Reviewed and approval of receiving inspection requirements and sampling plans for components; developed and improve QC inspection and testing method as needed; performed document control activities required by the QMS for the Lake Forest Facility including but not limited to document distribution, training, database entry and document revisions; coordinated the investigation and closure of CAPA and NCMR’s; leadership of cross functional root cause analysis team; evaluated product/material discrepancies and implement corrective actions accordant; complaint handling and participated in returned product investigations as required; supported manufacturing activities (process development and transfer, validations, etc); reviewed and approved document changes (process and design); maintained supplier qualification and part receiving requirements (ASL, FAI, Supplier Evaluation, Supplier Auditing, etc); participated in external/internal quality audits.

Senior Quality Engineer at Alcon

Quality representative and MRB facilitator during NCMR root cause investigations; Calibrations and DHR review and sign-off; worked with Receiving Inspection to ensure timely inspections, First Article sign-offs determining appropriate sampling plans and assisting in non-conformance evaluations; interacted with suppliers to align design requirements and Manufacturing expectations with capabilities and initiate SCARs when necessary; evaluated and initiated CRs (change requests) to improve process (Review of Non-Conforming Materials and Supplier Quality Assurance); responsible for training new Quality Analysts on the NCMR process, cycle counts, MRB disposition requirements and database management; provided monthly production metrics including Pareto charts of top non-conforming components for Management review; designated Quality representative for FDA and internal audit of NCMR process; CAPA implementation and effectiveness; suggested and implemented procedural changes reducing lost comp