- 21559 Kings Bend Dr.Ÿ Kingwood, XXXXXX xxxxxx ( (xxx-xxx-xxxx * abc@xyz.com

QA/QC Management/Quality Management Audit

Qualifications Profile

    Self-motivated and results-focused solutions provider in quality management with more than 16 years in quality control operations and 12 years in managing people mostly in the manufacturing and automotive industries.

-    Certified Quality Management Systems auditor and RAB/QSA Quality Auditor for ISO 9001.

-    Provided business-driven Quality Management Systems for ISO9001, and FDA standards, developing and incorporating updates required for new products, process improvements and adoption of best-of-breed practices.

-    Enhanced business competitive position with a strong passion for ensuring compliance in quality assurance standards and performance metrics for both in-house operations and 3^rd party contractors.

    Highly detailed and organized with analytical and methodical thinking to resolve QA issues even under stress.

    Strong people management and interpersonal communication skills that inspire confidence while forging teamwork synergies with colleagues across diverse ethnicities.

Key Expertise

    Tactical & Operations Planning

    Total Quality Management

    Statistical Quality Control

    Process/Workflow Improvement

    Continuous Quality Improvement

    Risk Management

    Kaizen and Six Sigma Methodologies

    Customer Service Management

    Relationship Management (Customers, Stakeholders, Public, Government & Suppliers)

    Policies & Regulatory Compliance (i.e. OSHA, ISO, RAB/QSA, US-FDA/cGMP/CFR etc.)

Technical

    Office Tools: MS Office (Word, Excel, PowerPoint, &Access)

Professional Experience

    Provide tactical directions in managing the Quality System, serving as ISO and ATEX Management Rep tasked with developing and executing 3^rd party quality system audits, managing compliance with ISO 9001 standard and ATEX addendums, and updating the Quality Management System as driven by new products and new procedures.

    Provide input and professional insights in executing Internal Audits, support in the evaluation and selection of quality-driven suppliers, while ensuring timely updates to the CAR/Supplier database system.

    Collaborate with external CM s and other suppliers to improve quality of incoming parts as per specifications.

    Conduct quarterly factory audits with various approval agencies (CSA, FM, ETL ) and prepare for required EPC related inspection/test protocols and documentation requirements.

    Provide HR support in training and coaching QA/QC Teams in optimizing quality control oversight in all aspects of production, while monitoring statistical metrics for continuing process improvement and ensuring compliance with all company EHS policies and best-of-breed practices.

    Assist with risk assessment updates, audits and Job Safety Analysis and maintain SOP involving safety precautions.

    Collect and process EHS data for recording and reporting purposes and conduct investigations in remediating and correcting incidents of non-compliance top quality and safety standards.

    Served as management representative and Lead ISO Auditor for the company s ISO 9001 quality management system.

    Implemented and administered quality assurance and quality control systems for the manufacturing processes.

    Developed and executed quality management procedures, work instructions, and inspection plans that ensured continuing operational excellence adhering to both customer expectations and quality management requirements.

    Implemented and maintained safety programs complying with OSHA guidelines and internal policies.

    Assigned and managed daily activities and assignments for quality technicians.

    Led and conducted root cause analysis in resolving process issues to ensure proper corrective actions

    Completed PPAP and FAI documentation requirements as customer requirements.

    Ensured compliance with customer contract requirements, coordinating with cross-functional teams in addressing customer issues and concerns, managing routine QA inspections following established performance standards and audit findings, including project scoping, financials, and critical path management for assigned process improvements.

    Support new business implementation & product changes, including process improvement and project management

    Served as Management Rep in all projects involving quality management under ISO 9001:2008 across the nation.

    Provided HR support in training new and existing production and quality staff and in assessing performance metrics in process quality and employee relations.

    Implemented various Lean and Six Sigma tools that saved costs in project improvement initiatives.

- 21559 Kings Bend Dr.Ÿ Kingwood, XXXXXX xxxxxx ( (xxx-xxx-xxxx * abc@xyz.com

Professional Experience (continued)

    Represented the company s ISO 9001 quality management system for facilities in the U.S. and Mexico implementing and maintaining the QA/QC systems for corporate and manufacturing facilities using the ACE systems.

    Collaborated with project management teams in meeting deliverables within projected timelines while reviewing and verifying all inspection plans and activities for each outstanding project.

    Reviewed customer requirements, adjusting production and inspection activities accordingly.

    Provided HR support in training and mentoring QA inspection personnel at all levels.

    QA/Compliance Manager, Thermadyne Holdings Ÿ Denton, XXXXXX Feb 0000 xxxxxx xxxx , xxxx , xxxxx 00000 for medical devices, regulatory adherence to FDA mandates under CFR 820, and Health Canada regulations for medical devices distributed in Canada.

    Led in implementing the company s global web-based quality management system.

    Collaborated with cross functional teams in developing and implementing quality standards for new product releases and project management.

    Led in process improvements and cost savings using several Kaizen events and Lean Manufacturing applications.

    Monitored product quality analyzing and reporting out-of-control situations for immediate corrections.

    Conducted supplier audits for accrediting suppliers based on price-performance rating.

    Conducted Root Cause Analysis training, 5S, and Blue Print Reading with new and existing employees.

    Managed the company s QSI portal quality management system for Document and Quality Records Control in issuing new and revised policies and procedures.

    Managed daily activities of QA/QC inspectors and quality technicians during the sub-assembly and sequence processes for the General Motors and Ford automotive facilities.

    Served as project lead across multi-disciplinary teams in transitioning the quality management systems from QS9000 to TS16949, managing ISO 9001 and TS16949 audits and process improvements as mandated by clients.

    Developed and modified inspection procedures and standards for plant operations, assisting the production teams with Lean Manufacturing and Six Sigma application and training.

    Updated Control Plans and PFEMA s in accordance with client process and design changes, reporting daily quality metrics and the analysis of customer feedback.

    Led root cause analysis in resolving customer complaints using the 8D methodology and Six Sigma Panel.

    Chaired of weekly and monthly best practice and corrective action meetings with cross functional team members

    Assisted in preparing annual budgets and monthly forecasts.

    Served as Project Quality Lead during plant startup and launch for the Chicago office servicing the Ford car plant.

Education & Credentials

    ARKANSAS STATE UNIVERSITY Ÿ Jonesboro, AK. - 2 years completed, no degree

    PHILLIPS COUNTY COMMUNITY COLLEGE Ÿ Helena, AK

Professional Training & Licensure/Certifications

    Trained Internal Auditor for ISO 13485 and cGMP/CFR 820 for medical devices.

    Certified RAB/QSA Quality Auditor ISO 9001:2008 & ISO 9001:2015

    Certified Quality Management Systems auditor

    Lean Manufacturing and Six Sigma

    Risk Management & Hazardous Locations Training

Professional Affiliations

    Member: American Society for Quality, and various other quality auditors social groups