Quality Assurance Plant Manager
Resume:
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*** ****** **, *** ** Duncan, SC 29334
C O N T A C T P R O F I L E
E D U C A T I O N
W O R K E X P E R I E N C E
Bacherlos Degree
Pontifical Jevariana University
2006-2010
Business Adminstration Management
Bachelors Degree
Pontifical Jevariana University
2010-2014
Science and Engineering
Sr. Quality Automotive Manager
R&E Automated Systems 2021- Present
Bilingual Sr. Quality Assurance Specialist with over 10 years of experience performing a variety of duties including, Quality Management, Supplier Quality Engineering, Process Engineering, Product Launch Engineering, Production Management, Plant Manager. Seeking to obtain a role where education and experience, along with leadership qualities, innovative and critical thinking strengths can be utilized to their fullest potential. Extremely versatile Corporate Quality Assurance Engineer experienced in Production/ Warehousing/Logistics/Quality Assurance positions. Reliable in leadership roles and can be depended upon to accomplish any task. My objective is to obtain employment with a reputable company, wherein I can secure a busy and challenging position that will allow me to continue to work with the same integrity, dependability, and enthusiasm I am accustomed to. L A N G U A G E S
English
Spanish
V I C T O R A M O L I N A
S R . Q U A L I T Y
A S S U R A N C E M A N A G E R
Design and implement long-term progressive Quality strategies and objectives that support the company’s Vision, Mission, Values, and long-term objectives.
Drive quality through the complete product life cycle from new product conception to after life support.
Develop metrics (internal/external) including the company’s cost of quality that drive identifying strategies and behavior to decrease the cost of quality while improving reliability and delivery times.
Identify, develop, implement, and administer appropriate policies, procedures, and workflow in accordance with industry standards and company strategies.
Administer and update Quality Programs, maintaining continued compliance with ISO 9001 requirements.
Directly manage the company’s Return Process and lead corrective action planning process at the business and Supply Base.
Work with Supply Chain to ensure appropriate controls in place to measure and audit Supplier Performance and Assessment.
Understand appropriate use of and capabilities of control charts and other measurement systems to drive process improvements. Work cross functionally with purchasing, operations, manufacturing engineering, and logistics.
Effectively use problem solving and process improvement methodologies such as Lean and Six Sigma to drive improvements for the business. Capable of communicating and training quality initiatives and programs to all employee levels. • Manages and Reports Key Performance Indicators to relevant interest parties. Indicators include (but not limited to): First Pass Yield, Parts Per Million, Rework Volume, Defects per Million Opportunity, customer warranty claims, etc.
Six Sigma Green Belt
IGGB Institute
2020
S R . Q U A L I T Y
A S S U R A N C E E N G I N E E R
Sr. Quality Assurance Engineer
PerkienElmer Science Inc.
Work with commercial teams in different European locations to ensure implementation and / or maintenance of QMS that are appropriate for Medical Devices / Life Sciences Manufacturing / Medical Devices Distribution and Services, ISO9001, IVDR and other applicable regulatory and statutory requirement.
Serve as a bridge between commercial and manufacturing teams, providing timely visibility and solutions to quality issues that impact commercial operations
Coordinate, plan and manage audits (internal / cross-sites). Facilitate external audit by certification body and support regulatory inspections by regulatory agencies.
Perform internal audits of processes, facilities and documentation to assure compliance with internal procedures and regulatory requirements. Establish, maintain and update relevant QMS documentation. Coordinate the Quality Management Review meeting on scheduled basis and prepares metrics and reports.
LMS administrative role for local procedure and practice. Conduct customer feedback / complaints and trend review, and drive appropriate continual improvement implementation.
Support all Quality compliance and regulatory activities. Support New Product Introductions, including representing the Quality Group at design & development meetings.
Be key participant in QMS Management Review Meetings. Own PerkinElmer Quality Scorecard for Hopkinton.
Act as a key interface with inspection agencies - TUV, CSA, etc. - along with resolution of issues identified.
Support the Regulatory Compliance Engineer to ensure compliance with standards - IVD, FDA, ISO 9001, 13485, etc.
Assists with the review of complaints to determine potential adverse events Assists with the department metrics and works with others to ensure department goals are achieved.
Remediation of product documentation for changes in product compliance for new or updated regulations (i.e., MDR, IVDR).
Participate/Lead projects related to Design Transfers Review technical product documentation including device master records (DMRs), drawings, bills of materials, test protocols and reports, manufacturing work instructions,engineeringchange orders (ECO), etc.. Work with manufacturingengineer/processengineerto ensure process controls are in place Review and/or approve reports for: test method validations, design transfer, pilot production, and process validations (IQ, OQ, PQ). Write, review and / or approved quality plans to support product activities both internal and external.
2020-2021
V I C T O R A M O L I N A
S K I L L S
FDA
SAP
Quality Management
KPI
SPC
Lean Principles
Data Science
MRP
Software Proficiency
Data Analysts.
Root Cause Analyst
Product Development
Internal Audits.
8D Problem Solving
Fishbone,Kaizen
3PL
ISO9001
VPS
FMEA
ISIR
Manufacturing
ERP Systems.
CAD / AUTO-CAD
CMM
DMAIC
A3 Report
APQP
5Whys
Laser Blade Welds
CAPA
PPAP
7Wasted
QMT
Lean Six Sigma Methodology
Ecoat System
Poka Yoke
SOP
LPA
Mini Tab
S R . Q U A L I T Y
A S S U R A N C E M A N A G E R
Sr. Quality Assurance Manager
Renault Automotive -SOFASA
Develop, implement, and maintain a standardized, organization-wide quality management system to the requirements of ISO9001:2015. Manages the Quality organization by providing work direction for all employees within the Quality Department including APL and non-APL positions.
Member of plant management and provides leadership, support and input into plant level decisions and overall plant direction within the vision of AMS leadership.
Interacts regularly with Engineering, Manufacturing and Service functions to establish quality standards for product release, raw materials, work in process and finished goods.
Regularly reports, to plant level management, the state of the quality management system and any output metrics such as warranty results and customer concerns.
Quality liaison providing support and leadership for Continuous improvement efforts and TOS implementation.
Review and approval of Process Deviation, Material Deviations, and Engineering Change Orders.
Manage and maintain Quality programs to ensure department and business objectives are being met.
Create and execute plans, Quality Management System, processes, and procedures to support plant PPM, Warranty Cost, and First Pass Yield. Ensure Quality controls and standards are maintained throughout the supply chain thru
surveillance audits and non-conformance reports (NCR’s). Maintain and report key performance metrics on the results of the quality management system (external warranty, internal PPM, customer satisfaction, etc.) to top management. • Investigates, resolves, and prepares reports for warranty claims thru Mercedes Rapid Response. Facilitate and promote problem-solving tools (Root Cause Counter Measure, 5 Why’s, Fishbone, Process Mapping, Benchmarking etc.). Support and manage technical staff responsible for inspections, documentation, and warranty claims.
Coordinates with local, regional, and global leaders to provide accurately and timely assessment and feedback of applicable processes (supplier performance, customer satisfaction, etc.)
Ensure that the quality function / mission is clearly communicated, and a quality plans are developed and fully implemented to support the mission.
2012-2020
V I C T O R A M O L I N A
Holding consecutive positions in Quality Assurance supervisory roles for civil and environmental engineering firms; playing a key role in investigating and correcting system/test methods and improving QA operations to reduce costs and enhance efficiency. Tracking and reporting on quality metrics in translatable terms; innovating and introducing new procedures and processes as needed to meet defined objectives. Managing vital quality control initiatives, compliance concerns, audits, and operational processes and procedures within corporate guidelines.
Communicating and collaborating with cross-functional teams—including engineers, project managers, and business development teams’to design new test methods to meet customer goals and realize continuous improvement.
Training, mentoring, and leading QA team members to ensure full understanding of internal procedures and drive effective integration of processes. Demonstrating outstanding analytical, staff leadership, problem-solving, and communication abilities. It is with great interest that I present to you the enclosed resume in response to the position you are looking to fill. As a highly skilled and accomplished professional with comprehensive expertise in quality assurance and validation, I possess a wide range of knowledge and experience that will allow me to contribute toward the success of your company.
My expertise lies in successfully managing teams, processes, and strategic programs to drive continuous quality improvement efforts through audits and special projects. Through my experience, I have amassed a breadth of knowledge in analyzing data and orchestrating project implementations, as well as ensuring compliance with local and federal regulations. Additionally, my established success in training and directing staff positions me to make a significant contribution to your organization. The following achievements demonstrate my qualification for this position: My dedication to maximizing quality assurance and validation efforts, along with my acute knowledge of quality audits and compliance issues, will contribute immensely to the success of your team. Thank you for your consideration. I look forward to speaking with you soon. T O W H O M I T M A Y C O N C E R N,
S I N C E R E L Y,
V I C T O R A M O L I N A
Victor A Molina
V I C T O R A M O L I N A
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