- A position in Quality Assurance in a fast - paced environment that will augment my experience in World Wide Medical Devices. me've been in Medical Devices per ISO 13485 for 23 years of my career. me've been involved from teh 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. me've dealt wif 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.
- me has participated in $12 million transfer during business integrations wifin United States and Mexico locations. me was teh QA representative to perform all teh training in regards of testing, visual defects, critical dimensions per engineer drawings, processes per Standard Operating Procedures and per customer requirements.
- me has interacted wif teh ISO Auditor in regards of teh processes and procedures in Quality Assurance, supported FDA audit and as well as onsite audit wif Suppliers/Vendors.
Confidential, Beverly, MA
Consultant Supplier Quality Engineer
- Managed all teh approved suppliers wifin teh U.S by adding, maintaining, changing & removing suppliers from Approved Supplier List (ASL) and update teh ASL in Ariba
- 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
- Non- Conformance (NC) Legacy reviewer to determine remediation level following protocol
- Risk evaluation to determine health and regulatory impact of teh NC’s
- 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 teh Complaint Handling Unit (CHU).
- Review Supplier’s CAPA and verify teh Action Activities and overall TEMPeffective verification’s prior to close teh CAPA
- Review retrospective’s CAPA base on FDA’s observations and overall TEMPeffective verification’s prior to close teh CAPA
- Conduct Suppliers onsite audit base on ISO 9001:2008, CFR Part 820 and ISO 13485 in Medical Devices
- Responsible monitoring external manufacturing, and vendors based on quality of teh 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 wif 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 wif Incoming Inspection reducing teh amount of rejects materials in teh quarantine cage by more TEMPthan 60% and review all nonconforming material for a quicker disposition and closure of NCRs.
- Conduct a monthly internal audit and Annual Quality Systems audit
Supplier Quality Engineer II
- Works wif external manufacturers and suppliers providing services, components and sub-assemblies
- Participate on Quarterly Business Review wif External Manufacturing
- Overseeing five suppliers to monitor their ongoing projects and their processes base on PFMEA
- Participates in Globally and wifin teh 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 teh protocols and support to execute teh 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 II
Confidential, Malvern, PA
- Prepares and reviews teh necessary documentation used in teh manufacturing and release of final product. Based on teh review of this documentation, makes recommendations to release or reject teh final product.
- Assures overall compliance wif internal specifications, external specification and FDA regulations.
- Responsible for maintaining lot history files, auditing teh manufacturing processes and assuring those documents are issued by teh manufacturing personnel according to appropriate SOP’s.
- Anticipates change and acts accordingly to release products in a timely manner. Communicate TEMPeffectively wif QA Supervisor if their were issues arise in regards of teh Systems. Complete all teh 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 teh 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 teh daily production meetings
- Track document error rates and other metrics indicator of quality assurance performance
- Completed and received Certificate of Quality Assurance Auditor by ASQ in Dec. 2009
- Completed a course in Drug Development at Temple University in 2009
- Completed a course in Food And Drug Law me at Temple University in 2008
Confidential, Langhorne, PA
Quality Assurance Supervisor
- Maintained and Monitors teh daily schedules to make sure teh production releases are completed
- Responsible for teh 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 wifin 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
- Assist in teh Operator Certification Program
- Responsible for QA/QC Inspection lab and lab prioritization
Confidential, Cherry Hill, NJ
Quality Engineer Technician
- Initiate Internal Corrective Action Requests against all excursions regarding environmental monitoring such as Bioburdens, Air Particles, Temperatures and Air Pressures in Manufacturing
- Communicate environmental monitoring results internally and to Corporate’s Regulatory department
- Update Standard Operating Procedures concerning environmental procedures
- Work wif Microbiologist to complete validations and determine environmental specifications in manufacturing areas
- Responsible to calibrate gauges, calipers, micrometers and audit all teh equipments that were used in Manufacturing wifin teh Calibration’s SOP’s Standards
Confidential, Cherry Hill, NJ
Quality Assurance Technician
- Trainer for noledge transfer during business integrations wifin United States and Mexico locations
- Participated in $12 Million Transfer during business integration
- QA representative to perform all teh training in regards of testing, visual defects, critical dimensions per engineer drawing and per customer requirements
- Audit device history records
- Supported an Internal Audit for compliance to ISO 9001 AND FDA QSRs in Manufacturing
- Work directly wif engineers and updated product sketches to strict quality standards, and utilized precision measurement equipment for inspection of final products
- Performed testing to all types of Medical Devices from Prototypes, Incoming Inspection, In-process to Finished Goods
- Performed First Article Inspections against Engineering Drawings or Customer Requirements.