Eva Rugel

Bilingual Quality Assurance Manufacturing Specialist

Email: ac2shu@r.postjobfree.com Home: 305-***-****

Career Goal: To obtain a challenging position in a high quality assurance environment in Ecuador (moving from US) where my expertise and academic skills will add value to organizational operations.

Professional Skill-sets: A highly trained/trainer with outstanding experience in quality assurance enforcement, laws and procedures, excellent time management skills, leadership, fluent bilingual (English/Spanish), analytical, and motivator.

Professional Experience:

Quality Supervisor November 2016 - June 2017

HOMETOWN FOODS

●Leaded the QA Dept.

●Trained the Manufacturing and Quality Personnel

●Leaded the external and internal Audits

●Supervised QA team (four members)

●Performed Operations Coordinator Team (Assisted Sanitation-Production and Maintenance crew)

Quality inspector November 2015 – August 2016

DEMETECH: Medical Device Co.

●Performed Inspection in Process and Finished Good

●Reviewed updating and closing Device History Record (DHR)

●Approved artworks to release Manufacture Orders (MO)

●Developed a procedure to release product and avoid delays shipments to the customers

●Developed Work Instructions (WI) and Quality Assurance Reports (QAR)

Quality Coordinator: Contract January 2014 – September 2015

OFFSET ABAD: Graphic Industry

●Created the Quality Assurance Department and assisted the President of the Co. in multiple leading operational meetings regarding the strategies for developing new QA plans and strategies.

●Coordinated departmental trainings and assisted other operational needs to increase efficiency, reduce waste of material, and reduce customer complaints matters

●Trained the operation staff about QA standards, process to be competitive, and their benefits.

●Assisted the procurement department in buying appropriate tools to upgrade the machinery equipment to improve the standardized quality standards of products.

●Helped monitoring production control data and assisted in taking corrective-preventive actions (CAPA) for any noticeable trends to eliminate customer complaints. Monitored Non-conformance Reports (NCR)

●Worked closely with Planning Production, Logistics, and Sales departments with Contract Review meetings to achieve the date of delivery products committed to the customers.

●Responsible for managing the implementation of control documents all operation (development, review, and update) such as work orders, GMP, WI, SOP, inspection forms, Engineering Change Operation ECO, training records, and Engineering Change Request (ECR)

●Performed Internal Audit and external Audits

Document Control (Contract July 2013 – December 2013)

GENESYS CONTROL AUTOMATIZATION (Supplies instrumentation and control solutions for oil and gas)

●Developed and maintained a comprehensive filing system and computer database for all documents to be retained in the document control center to ensure that all users have the latest revision of appropriate documentation in a timely manner.

●Prepared Daily Reports, weekly, and monthly Commissioner Working Hours.

●Coordinated the distribution of controlled documents to the appropriate staff.

Quality Assurance Specialist (November 2010 – May 2013)

POCHET OF AMERICA: Glass Industry

●Quality gatekeeper role extended to conducting numerous department internal audits and passing, retaining ISO accreditation.

●Performed and ensured all quality assurance assignments of standard procedures are appropriately done.

●Performed internal and external audits.

●Prepared presentations and other learning tools for training the production/QA staffs.

●Oversee the release of current revision levels of drawings, specifications to production, quality control, customer service, customers and engineering department.

●Leaded and/or member of an audit team to ensure compliance with Company policies, practices and procedures.

●Coordinated corrective and preventive actions.

●Created and issued work orders according to the monthly schedule.

●Participated in the implementation and approval of new processes/products.

●Monitored calibration log and equipment maintenance.

●Responsible for supporting Quality team by Design activities linked to production operations

Document Control Specialist (November 2007 October 2010)

PARAGON MEDICAL CO: Medical Devices Co.

●Verified the Quality Management System was properly implemented and monitored.

●Utilized and participated in maintaining systems to perform filing submissions, research, audits, and other functions relating to compliance with state and federal regulations.

●Verified that the ISO 13845, ISO 9001, and FDA requirements are implemented.

●Responsible for the training of staff at GMP in different functional disciplines.

●Assisted the CAD/CAM engineers in developing processes at par with the QA policies and standards

●Established an exceptional customer service with subcontractors to obtain documentation regulated for Approved Supplier List (ASL)

●Development and Process Improvement, nonconformance management, CAPA and root cause analysis.

●QMS training, document and record control and Engineering Change Orders.

●Product acceptance activities inspections and testing.

●Experience with Regulatory Submissions, Internal Audits.

●Oversee internal contract manufacturing quality activities for product acceptance activities, Device History Record (DHR) review and approval, Documentation Control and ECO process management, component and product non-conformance.

●Assessed the quality of raw materials being delivered by the suppliers.

Quality Supervisor (2004 - 2007)

CANFIL FARR INC: Biopharmaceutical Industry

●Provided Quality Assurance training and preparing staff performance evaluations.

●Conducted / Assisted the Engineering team reviewing new contracts prior to manufacture.

●Promoted CRS (Customer Response System) and eliminate customer complaints.

●Directed the CAPA process.

●Participated in Lean events to improve production efficiency and eliminate waste of materials

●Implemented electronic records for accuracy and expedited the recovery process therefore.

●Trained (ESL) English as a second language to production staff.

●Established issues requiring in-depth analysis to manager for troubleshooting and problem-solving.

●Experience with 21 CFR 820 and ISO 13485 compliance and internal auditing, and FDA inspections.

●Development and Process Improvement, nonconformance management, CAPA and root cause.

●Monitored the (ECO) Engineering Change Orders process.

●Managed and executed internal and external audits.

EDUCATION: Bachelor in Chemistry and Biology (Certified and validated by World Education Services)

Certificates:

●Safety Quality Practitioner

●Internal Auditor ISO 9001:2008

●Glass Manufacturing

●Lean Logistics

●Microsoft Specialist II: Excel, Word, Power Point, Outlook, and Access

●How to be a Better Communicator

●Successful Communication Skills For Women

●The Essentials of Communicating With Diplomacy and Professionalism

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