SUMMARY:

• I am a technical professional wif years of Quality experience equipped wif an arsenal of impactful skillsets. My diversified experience includes Medical Device manufacturing, Industrial Project Management, and currently Industrial Heat Exchanger Manufacturing. I am a team player who brings value to any organization through initiative, decision making, problem solving and leadership skills.
• I am seeking a Quality Management / Leadership position. My skills include TEMPeffective customer interaction, excellent organization, and technical writing skills. I am noledgeable in all aspects of Quality Management.
• I am proficient in the development of Quality Systems concentrated around ISO 13485, ISO 14971, and ISO 9001 Regulatory requirements. I am self - motivated and goal oriented. I am passionate about learning and inspire to be a major contributor in my organization.

PROFESSIONAL EXPERIENCE:

Confidential

Quality Specialist

Responsibilities:

• Quality Representative for all onsite Compliance and Customer Audits Responsibly for sitewide quality related Responsible for Supplier relationships and Supplier Quality Oversee Document Control functions and all traceability Develop Quality Control Plans & Inspection Criteria Participate in cross functional teams in the development of FMEA and Process Flows Lead Customer Complaint Process and RMAs CAPA programs using 8D, Fishbone Techniques Ishikawa Diagrams
• Create and Process all supplier SCARs and validate completion Collect and present d Confidential for Departmental and Site KPIs reporting Develop processes to Develop, implement, and track Quality System Documents and process Maintain and Process all PCPs Complete and Approve all PPAPs submissions Quality Lead for new Product development Maintain plant wide gauge calibration Log and trend daily leak rates Completed scheduled process audits and implementing audit program Maintenance and development of ultrasonic cleaning process Act as liaison team member between customer and the company

Confidential

Quality Systems Technician II

Responsibilities:

• Medical Device Manufacturer Preform Quality Control Inspection on dialysis drug/medical device combo products Review Engineering specifications / drawings Create Quality Control inspection standards Inspect and coordinate rework Enforce Pharmaceutical GMPs and ISO 13485 Compliance Oversee inspection equipment calibration Review Device History Records and Sterility RecordsQuality System Services / Compliance Consulting Independent Contracting (PRN) Provide regulatory consulting and contract work to Life Science / Medical Device companies Perform Gap Analysis to current regulatory standards (ISO 2016, ISO 9001) Prepare technical files for regulatory submissions Review Engineering specifications / Drawings Create Quality Control inspection standards Create Quality Assurance

  Auditing tools Preform 3rd Quality Audits (Desk Audits) Write Standard operating procedures and work instructions Prepare 510(k) documents Review and summarize technical reports (Mechanical Tests /Sterilization/ Risk Management Reports) Conduct clinical research to support regulatory submissions to determine substantial equivalence Analyze Customer feedback (Complaints\ MDR\PMS D Confidential ) Create presentations Prepare Quality Manuals for medical device companies Compile and organize Quality Records for archive Prepare Document Control Records

Confidential

Office Nurse

Responsibilities:

• Assists in examination and treatment of Confidential ts under direction of Physician or Nurse Practitioner Interviews Confidential ts to obtain medical history and status Measure Confidential t vital signs and records information in
• EMR Assists in Confidential t scheduling and diagnostic testing Coordinates and schedules referrals Administers Medications and injections in office Submit and manage prescriptions electronically for providers Calls Confidential ts to relay lab results from provide

Confidential

Maintenance Project Manager

Responsibilities:

• Manage multiple contracts that include cost control, maintenance of equipment, procurement of materials, selection of contractors, scheduling, project development, billing, and customer satisfaction.
• Scheduling maintenance for national accounts up to 1000 locations Weekly client invoicing and follow up Vendor screening and selection Purchasing activities associated wif replenishment of materials. Communicate wif customers and field installers to coordinate job specifications and maintenance timelines

Confidential

Senior Quality Specialist II

Responsibilities:

• Perform internal audits in accordance wif 21 CFR 820, ISO 13485:2003, MDD 93/42/EEC Managed Inspection personnel and prioritized task for QC Team Inspect medical devices wif optical comparator/inspection gauges/ CMM Prepare Quality inspection criteria sheets / Quality Control Plans Maintain Non - Conforming Logs Coordinated CAPA teams Participate in Material Review Boards to assign disposition to non-conforming parts.
• Serve as the Quality Representative on new product development teams, develop the Quality Plans, coordinate and review the validation activities, work wif manufacturing to ensure manufacturability of new products, review and approve design drawings Perform investigations of non-conforming parts to determine root cause Maintain calibration of gauges / instrumentation Collect d Confidential for Process Capability Studies and Gauge R&R studies Perform Final Inspection and release for finished goods Ensure 1st article inspections comply wif specifications Processed QC Department Document Control functions

Confidential

Quality Technician

Responsibilities:

• Monitored FIFO of sterile medical supplies Processed and Reported monthly sterility dose audit Quality inspection of medical devices Preformed Receiving and final Inspection Shift Lead of QC Inspection Maintained supplier files and scorecards Performed investigations of non - conforming implants to assign a disposition
• Maintained calibration of gauges / instrumentation Maintained Engineering D Confidential bases of Design History Files Prepared Quality Control Plans Operated the CMM, vision system and Optical Comparator to perform inspection Perform internal audits

Confidential

Medical Clinic and Lab Assistant

Responsibilities:

• Obtained and documented Confidential t's medical history, drug history, complaints and allergiesTook Confidential t vital signsMaintained accurate records of Confidential t care, condition, progress and treatments for PhysiciansAssisted in Confidential t schedulingMonitored expiration and inventory of medical supplies and medicationsPerformed clerical duties, such as word processing, d Confidential entry, answering phones and medical filing.
• Prepped Chemistry and Biology labsPerformed maintenance and maintained calibration of lab equipmentMaintained Laboratory chemicals and suppliesAssisted in of new lab assistantsPrepared specimens for routine laboratory assays/ dissection