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Senior Quality Engineer Resume

Eatontown New, JerseY

WORK EXPERIENCE:

Senior Quality Engineer

Confidential, Eatontown, New Jersey

Responsibilities:

  • 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.

CAPA Engineer

Confidential, Lake Forest, California

Responsibilities:

  • 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:

  • 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

Responsibilities:

  • 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.

Responsibilities:

  • 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.

Quality Supervisor

Confidential - Aurora, Ohio

Responsibilities:

  • 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.

Manufacturing/Electrical Engineer

Confidential, Clinton, New Jersey/Strongsville, Ohio

Responsibilities:

  • 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

Responsibilities:

  • 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.

Test Engineer

Confidential - Torrance/Mountain View, California

Responsibilities:

  • 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 .

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