Senior Quality Engineer
Confidential, Eatontown, New Jersey
- Led the service repair work stream to integrate Compression Therapy Concepts(CTC) into Confidential Quality Management System(QMS).
- Developed and implemented procedures to addressed Internal audit findings in the repair department.
- Developed and validated Final acceptance procedure of CTC medical device.
- Performed gap analysis a to develop additional processes procedure to comply with ISO 13485 Rev 3 and 21 CFR 820 Utilized IEC 60601 - 1 Rev3 and UL 6060-1 Rev3 to set up Electrical safety test for CTC medical device.
Confidential, Lake Forest, California
- Responsibilities include review of aging CAPAs for proper content (GDP, root cause, containment, risk assessment, action plans, etc).
- Ensure that every activity performed in the CAPA process is accurately documented and that all time frames for reporting or resolution are met.
- Developed a CAPA Review Board (CRB) process and led CRB meetings.
- Perform Investigation and corrective action to internal audit observation.
Validation Engineer/Quality Systems.
Confidential, Irvine, California
- Responsibilities include providing quality engineering guidance and support to the Corrective and Preventive Action (CAPA) process.
- Collaborate with representatives from other functional areas to facilitate timely and effective Corrective and Preventive Action (CAPA) investigations, action plan, risk analysis (FMEA/ PFME), implementation and effectiveness monitoring. Administered (ETQ) CAPA data base and led CAPA Review Board.
- Reviewed Validation and Test reports, Hazard Analysis, DHF, DHR, NCR, IQ, OQ, PQ, and SACAR to insure they were complete, accurate, and Focused (understandable).
- Performed monthly audit reports, and prepared metrics for Management review Documented all action in ETQ NC, and CAPA data bases
Senior Product Safety Analyst
Confidential, Santa Ana, California
- Responsible for maintaining the quality processes related to AMO post-market product complaints and ensure compliance of all applicable Corporate and Divisional policies and procedures.
- Analyzes complaint data on the Phacoemulisfication system to identify any trends and provides information that may lead to a CAPA or MDR.
- Coordinated complaints with internal and external suppliers to complete investigations and close files.
- Utilize the CATSWEB NC/Complaints Process and CAPA process to document, audit, approve, and close files.
Senior Quality Assurance Engineer
Confidential, Dallas, Texas.
- Responsible for remediation of CAPA’s on active implantable neurological devices; (DBS) Direct Brain Stimulators and (SCS) Spinal Center Stimulators in response to FDA Warning Letter.
- Took ownership of CAPAs and determine Root Cause, Risk assessment (CFMEA, Hazard Analysis), Corrective action, Implementation, and Effectiveness check.
- Project Team Member of the Complaint and MDR QSIP to remediate customer complaints, responsible for linking customer complaints to failure modes to determine if a MDR is necessary.
- Utilized the CATSWEB NC/Complaints Process and CAPA process to document, audit, approve and close files.
Confidential - Aurora, Ohio
- Responsibilities include for developing, implementing, and maintaining an ISO 9001 QMS; (Quality Management System).
- Performed quality inspections of; PCBA, sub-assemblies, and metal parts.
- Developed (WI) Work Instruction, (QA) Quality Assurance instructions, (SOP) Standard Operating Procedures,(RI) Receiving Inspection, Testing instruction, and Calibration procedures.
- Directed workers in quality assurance inspection and testing, to assure that standards and good quality product are met.
- Developed reports and made suggestions to improve quality processes and products.
Confidential, Clinton, New Jersey/Strongsville, Ohio
- Acted as a 3rd party to support manufacturing to assisted in manufacturing problems and quality issues for the INOMAX DS.
- Reviewed NCR to investigated failure and determine DPU (Defects Per Unit).
- Troubleshot INOMAX DS to determine root cause of failure.
- Performed statistical data analysis to determine Confidential, identify failure modes, and propose possible product improvements.
- Microsoft Excel, Word, Visio, Applications.
Research Associate- Product Support.
Confidential, Irvine, California
- Compiled, reviewed, and closed complaint files in response to a FDA Warning Letter. Analyzed and evaluated OM2 (optical modules) and 70cc2 patient cables to determine root causes and failure modes.
- Trended failure data for Patient cables used for INVITRO and INVIVO Patient Diagnostics Analysis.
- Implemented new procedures (SOP) to evaluate patient cables and developed new failure codes for improve data collection and trending.
- Conducted a Wiebull data plot to determine the percentile life for Patient cables. Complied with ISO 14971, IEC 60601-1/UL 60601-1, in evaluation of electrical patient cables, used MS Word, Excel, Visio, PowerPoint, Statgraphics Applications in reporting and evaluating results.
Confidential - Torrance/Mountain View, California
- Responsibilities included the planning and implementing data collection utilizing Electrochemical Impedance Spectroscopy to evaluate lead-acid batteries.
- Programmed biphasic power supplies, and Dynaloads using LabVIEW to control instruments; collected voltage, current, and time data.
- Built test fixtures and maintain strings of Lead-Acid batteries .