Quality Assurance Specialist Resume Sylmar CA - Hire IT People

SUMMARY

Experience Document Control, Internal Auditor and Regulatory Support with over 25+ years of experience in the medical device manufacturing industry both IVD and Implants. Extensive training with a background in quality systems, control of documents process, and procedures, including record management, record retention, regulatory affairs and internal audits. Exceptional computer skills in Microsoft Office Suite, Word, Excel, Power Point, Visio, SharePoint, PDM Works, Acrobat, EDMS, MasterControl, EtQ, Reliance and cPDM. Extensive knowledge in Inventory Maintenance programs in MAS90/200, Oracle and QAD. Ability to

PROFESSIONAL EXPERIENCE

Confidential, Sylmar CA

Quality Assurance Specialist

Responsibilities:

Internal Audit Program Management, Audit Oversite, Wrote, Updated and Maintained the Audit Schedule, Controlled Back Room for Notified Body Audits
Maintained Document Control process, Quality Records and updated Inventory Maintenance Software with Revision and BOM updates
Scripted, Validated, Verified, Reviewed and Approved QMS Software, Releases and Changes
Wrote, Updated, Reviewed and Approved SOP’s, DOP’s, WID’s, SPEC’s, Drawings, etc. for Accuracy, Streamlining, and to cut waste and cost to the processes
Completed the collection and monitoring of quality data metrics for accuracy to company policies and requirements for manufacturing lots, shipping, receiving and sterilization process
Controlled and ensured personnel were Trained on requirements per their job functions and that the training was effective
Participated in investigations to effectively identify the root causes with applicable corrective actions, preventive actions and deviations to mitigate reoccurrence
Supported in regulatory compliance actions, such as: monthly and quarterly reporting; agency inspection support; and, data logging and reports
Manage the risk assessments conducted, analyze trends and integration into area owned standard operating procedures
Influence and collaborate with key stakeholders cross - functionally within Manufacturing, QC lab, Critical Systems, Maintenance, and Engineering organizations to provide support and assure compliance with applicable federal, state, and local requirements
Safety Team and Employee Activity Committee member

Confidential, Chatsworth CA

Document Control/Internal Auditor Lead

Responsibilities:

Document Control Specialist
Internal Auditor Lead, Audited Suppliers and Subsidiaries
External Standard Coordinator
Oracle Professional Lead and Administrator
Regulatory Affairs Associate/Specialist
Incorporated labeling process to GS1, GTIN, GHS, UDI
Maintained GLPs, GMPs and GDP’s
Safety Team and Employee Activity Committee member
Training Coordinator Lead
Validated and Implemented onsite Oracle

Confidential, Chatsworth CA

Document Control Supervisor

Responsibilities:

Lead Administrator to the Director of Regulatory and Quality Affairs
Internal Auditor Supervisor, Supplier Auditor and Subsidiary Auditor (Full Scope Audits)
Supervisor of internal documentation process, data management and record updates release and change control processes
Lead Federal, State and International documentation requirements and required disclosures
Lead ERP/MRP System and database
Lead Corrective and Preventive Action Process
Updated and wrote SOP’s, DOP’s and Work Instructions
Ensured accuracy and integrity of Document Control, Data Control and Record Retention process
Supervised Document Control Clerk(s) to ensure timely and accurate workflow
Lead labeling projects
Safety Team and Employee Activity Committee member
Validated and Implemented Solidworks (Used as the QMS System)

Confidential, Chatsworth CA

Document Control Specialist Lead/Supervisor

Responsibilities:

Responsible for organizing and managing all documented related activities - including all MRP updates
Lead the company’s ISO 9000/ISO 13485:1997 implementation and maintenance
Lead all product release, Change Control process and updates
Lead multiple functions to ensure proper compliance with policies and procedure for Marketing, Engineering, Software and Manufacturing Groups
Internal Auditor
Safety Team and Employee Activity Committee member
Set up the ESD system and maintained the Requirements
Validated and Implemented MAS200

Confidential, Chatsworth CA

Printed Circuit Board Assembly Lead/Supervisor

Responsibilities:

Supervised the control and planning of the Printed Circuit Board Manufacturing Department
Supervised “Pick and Place” machine including daily maintenance and programming
Produced and distributed work orders to assembly line to meet scheduling
Supervised Assembly Line workers and responsible for training new hires
Created and maintained all associated SOP’s, DOP’s, drawings and forms required for the Printed Circuit Board Assembly area

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Quality Assurance Specialist Resume

Sylmar, CA

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