SUMMARY

• An Enthusiastic professional with 10+ years of experience in the medical device manufacturing industry supporting manufacturing, quality and R&D.
• Comes with 5+ years of experience in Quality Assurance/Quality Control/Change Control with Medical Device Companies; Boston Scientific/Vessix Vascular, Dexcom, Abbott, Providien, BD, Confidential and D&K Engineering.
• Experienced in processing NCMR’s, Process Deviations, Corrective Action, Supplier Management, Management, Master List and Change Management, and Equipment Management.
• Performed Documentation Services tasks (Created and processed Change Requests).
• Review and approve quality records (test data sheets and program records)
• Supported Quality, R&D and Manufacturing/Operations in various tasks from design development to full commercialization.
• Performed incoming inspection of product components and maintained quality records.

TECHNICAL SKILLS

• Computer skills: Confidential (Windows 10, Word, Excel, Outlook, OneNote, PowerPoint), Adobe Acrobat Standard, RAM, Confidential, Omnify, IQMS, Agile, Aras, IFS ERP system, SAP
• s: Six Sigma Green Belt .
• Documentation: Manufacturing Process Instructions, Visual Standards, Test Methods, Engineering Request, Change Orders, NCMR, Process Deviations, Complaints.

PROFESSIONAL EXPERIENCE

Confidential, San Diego, CA

Quality Assurance Specialist II

Responsibilities:

• Initiated complaints, recorded investigations, assigned SME and managed through closure.
• Initiated NCMRs, documented phases and monitored through closure.
• Processed change orders from initiation, review for GDP, routed and closed.
• Managed calibration of all lab equipment. Scheduled with calibration service suppliers as needed. Reviewed data and calibration s for accuracy. Online auditing of calibrated equipment for compliance.
• Performed in process batch review and finished goods review for release.
• Managed and updated all records in binders utilizing a paper - based system.
• Reviewed IQ/OQ/PQ for compliance and approved for release.
• Performed metrics for change order process for quarterly Management Review meetings.
• Participated in third party audits from regulatory bodies.

Confidential, San Diego, CA

QA Analyst II

Responsibilities:

• Create and revise documentation as needed
• Review and approve quality records, DHR’s and batch records.
• Train production staff
• Create and process deviations and followed through with quality engineering in regard to product impact.
• Release product and create CofC’s for customers.
• Manage MRB quarantine cage.
• Revise QA inspection checklist based on trends.
• Work with customers to establish inspection criteria.
• Initiate NCR’s and evaluate for root cause and disposition as needed.
• Performed production line audits for 5S, GDP and general compliance.
• Documentation: Change Orders-various documents.

Confidential, San Diego, CA

Quality Assurance Specialist

Responsibilities:

• Reviewed electronic and hard copy calibration, maintenance and repair records for accuracy and GDP.
• Approved/rejected completed work records and provided input to technicians for correction as needed.
• Performed RAM database management and maintenance to ensure accuracy and integrity of data.
• Reviewed and approved/rejected work requests submitted by end users and converted requests into work orders.
• Assigned incoming RAM work orders to technicians and scheduled WO priorities with end users and technicians.
• Generated weekly and monthly reports for work order tracking and reconciliation for management review.
• Processed out of tolerance records and assigned work to investigators, approvers and QA.
• Updated records in RAM with new/revised specification information and all associated requirements.
• Performed internal audits on equipment to verify compliance to calibration procedures.
• Performed internal audit on calibration technicians to verify compliance to calibration processes and procedures.

Confidential, Oceanside, CA

Manufacturing Technician IIII

Responsibilities:

• Set up and troubleshooted production equipment.
• Instrumental in the process development of product for current and new customers.
• Performed notebook studies to determine process flow for creating travelers for each product line.

Confidential, San Diego, CA

Quality Control Specialist

Responsibilities:

• Performed supplier audits of vendors to verify compliance to regulations.
• Performed work order quality reviews.
• Contacted vendors regarding missing documentation (C of C, Specifications, etc.)
• Performed internal audits of production and process inspections during process runs.
• Performed RMA’s through IQMS quality system.
• Initiated NCMR’s when appropriate.
• MRB Assignment- Collected evidence of defect or damaged material. Contacted vendor for credit and processed documentation for RTV.

Confidential, Laguna Hills, CA

Quality Technician III

Responsibilities:

• Performed Final Batch Release testing on commercial product.
• Performed receiving inspection on product components.
• Processed labeling and shipping of commercial product.
• Performed onsite inspection of components at Vendor sites as needed.
• Performed various functional testing and inspections as needed during design development and validation.

Confidential, San Diego, CA

Q.A Technician

Responsibilities:

• Processed commercial and clinical Returned Goods including decontamination of devices.
• Downloaded device data for analysis.
• Created and compiled all appropriate forms and documentation.
• Received and logged all returned goods.
• Managed and organized cycle counts for process flow and efficiency

Confidential, Carlsbad, CA

Responsibilities:

• Chemical Handling (i.e. toluene, fentynal, ethynal)
• Set up and operated mixing equipment.
• Mixed adhesive formulation for fentynal transthermal patch.
• Setup and operated coating equipment for fentynal transthermal patch.