SUMMARY

• A position in Quality Assurance in a fast - paced environment that will augment my experience in World Wide Medical Devices.
• I've been in Medical Devices per ISO 13485 for 23 years of my career.
• I've been involved from the in-process of manufacturing, incoming inspection, Quality Control, Quality Assurance and External Manufacturers and suppliers as well as provide guidance and support validation activities (Master Validation Plan, IQ, OQ, PQ and PFMEA) to internal and external manufacturers and suppliers.
• I've dealt with all types of raw materials from electrical and mechanical components that apply to medical devices from prototypes to finished goods.
• Performed root cause analysis base on SCAR, nonconforming material and CAPA in internal and external manufacturing in globally and Suppliers/Vendors.
• I have participated in $12 million transfer during business integrations within United States and Mexico locations.
• I was the QA representative to perform all the training in regards of testing, visual defects, critical dimensions per engineer drawings, processes per Standard Operating Procedures and per customer requirements.
• I have interacted with the ISO Auditor in regards of the processes and procedures in Quality Assurance, supported FDA audit and as well as onsite audit with Suppliers/Vendors.

PROFESSIONAL EXPERIENCE

Confidential

Consultant Supplier Quality Engineer

Responsibilities:

• Developed a process for electronic filing system in Database (DocuSphere) and placing all related Supplier documents in DocuSphere
• Ensured and monitored Supplier Changes are close in timely manner
• NC review and classification of deficiencies to determine final remediation level
• Responsible for writing Action Plans for each assigned NC describing deficiency and remediation activities and escalate issues when necessary to the Complaint Handling Unit (CHU).
• Responsible monitoring external manufacturing, and vendors based on quality of the products
• Responsible of mentoring Incoming Inspection to utilize a better inspection method of all components
• Issue SCAR “Supplier Corrective Action Request” based on an ongoing nonconforming material and collaborate with suppliers regarding of an action plan of preventing of re-occurrence nonconforming material
• Review suppliers PFMEA/Control plans, CAPA’s response and risk assessments
• Perform a monthly review for suppliers nonconforming material by calculating suppliers DPM “Defects per Million”
• Support all senior levels Auditors to issue suppliers pre-assessments
• Create a daily review process with Incoming Inspection reducing the amount of rejects materials in the quarantine cage by more than 60% and review all nonconforming material for a quicker disposition and closure of NCRs.
• Conduct a monthly internal audit and Annual Quality Systems audit

Confidential

Supplier Quality Engineer

Responsibilities:

• Works with external manufacturers and suppliers providing services, components and sub-assemblies
• Participate on Quarterly Business Review with External Manufacturing
• Overseeing five suppliers to monitor their ongoing projects and their processes base on PFMEA
• Participates in Globally and within the United States conference call to discuss that’s ongoing projects
• Issue Nonconforming Material Report and CAPA to Suppliers base on an ongoing failure
• Review Supplier’s Master Validation Plan, IQ, OQ, PQ and provide feedback and signed off on the protocols and support to execute the PQ
• Support a non GMP Suppliers to establish a GMP procedures for Medical Devices
• Facilitates understanding of product specifications to allow for supplier delivery of product requirements
• Support validation activities related to process or material/component changes at external manufacturer

Quality Assurance Analyst

Confidential

Responsibilities:

• Prepares and reviews the necessary documentation used in the manufacturing and release of final product. Based on the review of this documentation, makes recommendations to release or reject the final product.
• Assures overall compliance with internal specifications, external specification and FDA regulations.
• Responsible for maintaining lot history files, auditing the manufacturing processes and assuring those documents are issued by the manufacturing personnel according to appropriate SOP’s.
• Anticipates change and acts accordingly to release products in a timely manner. Communicate effectively with QA Supervisor if there were issues arise in regards of the Systems. Complete all the requirements in process and final, prior to release documentations to Manufacturing personnel.
• Audits complete batch records for correctness and completeness of documents according to appropriate SOP’s. Determine release/reject disposition of products, components and complete all the requirements documentation prior to release for shipping
• Participates in Quality Assurance improvement and training projects
• Identifies quality problems to QA management and recommend solutions and actively participates in resolution of documentation and compliance issues
• Provides back up to QA Supervisor for QA representation at the daily production meetings
• Track document error rates and other metrics indicator of quality assurance performance

Confidential

Quality Assurance Supervisor

Responsibilities:

• Maintained and Monitors the daily schedules to make sure the production releases are completed
• Responsible for the overall direction, coordination, and evaluation of QA/QC Inspection activities
• Responsible for product acceptance and release
• Interviewing, hiring, firing and training employees; planning, assigning, and directing work
• Working within a budget for QA/QC, auditing, training, and compliance activities
• Train personnel for Quality System procedures and supports training records
• Conduct/manage periodic internal audits and cGMP training activities
• Initiate and review Certificate of Analysis and Certificate of Conformance forms.
• Coordinate of Material Review Board (MRB)
• Analyze and disposition all Return Material Authorization (RMA)
• Support GMP activities release of material. Inspect and verify product labels and inserts
• Implementation and Management of Component Material Specifications, Batch History Records, Quality Records & Procedures and Inspection and Test Records
• Responsible for QA/QC Inspection lab and lab prioritization