Mark Woodruff

Salem, WI ***** Home: 262-***-**** Cell: 262-***-****

ad44oo@r.postjobfree.com linkedin.com/in/mark-woodruff-95957211

Professional Profile

With seven years of experience as a Supplier Quality Engineer at Cree Lighting, I have demonstrated proficiency in driving supplier corrective actions, overseeing production part submissions, and leading audits to ensure compliance with various ISO standards with a track record of reducing non-conforming materials and improving receiving inspection processes.

My role at Vesta Inc. as a Quality Supervisor, with my team was involved in ensuring product quality and compliance with FDA regulations. As Quality Manager at Plastic Molded Concepts, I managed an effective quality system and material compliance across various industries.

With nearly two decades of experience at ITW Filtertek as the sole Quality Engineer, involved me in all aspects of quality assurance compliance and system auditing for medical, automotive, and industrial sectors. My military service further underscores my discipline and commitment to excellence. I bring a robust set of leadership skills to the table and possess a comprehensive skill set, leadership acumen, and a proven track record of driving operation excellence across many diverse industries.

With seven years of experience as a Supplier Quality Engineer at Cree Lighting, I have demonstrated proficiency in driving supplier corrective actions, overseeing production part submissions, and leading audits to ensure compliance with various ISO standards with a track record of reducing non-conforming materials and improving receiving inspection processes.

My role at Vesta Inc. as a Quality Supervisor, with my team was involved in ensuring product quality and compliance with FDA regulations. As Quality Manager at Plastic Molded Concepts, I managed an effective quality system and material compliance across various industries.

With nearly two decades of experience at ITW Filtertek as the sole Quality Engineer, involved me in all aspects of quality assurance compliance and system auditing for medical, automotive, and industrial sectors. My military service further underscores my discipline and commitment to excellence. I bring a robust set of leadership skills to the table and possess a comprehensive skill set, leadership acumen, and a proven track record of driving operation excellence across many diverse industries.

Core Competencies:

Collaborative / Innovative Leadership Skills

Lead Quality System Auditor

Strategic Planning / Implementation

Cost Reduction Strategies

FDA and ISO (CFR Part 820, ISO13485, ISO14001, ISO9001 and ISO/TS16949)

Appraise Internal/External Quality Systems

Quality Training

Build Effective Relationships with Internal/External Suppliers

Process Design

Supplier Improvement

Project Management

Process and Product Improvement

Internal/External Problem Resolution

Six Sigma

Manage Non-Conformances, Root Cause & Corrective Actions

Safe and Healthful Work Environment

Work Experience

CREE LIGHTING, Racine, WI 01/2017 – 03/2024

Worldwide manufacturer and marketer of lighting-class LEDs, lighting products.

Supplier Quality Engineer

Ensured effectiveness by generating Supplier Corrective Action Reports (SCAR) and drive root cause and corrective action with suppliers to ensure effectiveness.

Perform audit manufacturing processes of suppliers for verification of continuous corrective and preventive action effectiveness.

Resolve internal and supplier nonconforming product and find resolution of internal and external quality issues.

Review and approve all Production Part Approval Process (PPAP) documentation for readiness of new production products for all Metals, Plastics, and Optics commodities.

Revise and update quality system and procedures and work instructions as necessary to initiate and better define processes.

Perform Internal and Supplier assessment Audits of external and internal Quality Management System.

VESTA INC., Franklin, WI 11/2014 – 09/2016

Manufacturer of clean room silicone molded devices and components for the global healthcare industry.

Quality Control Supervisor

Assured product quality (incoming raw materials and components, developmental products, WIP and finished goods) and compliance to FDA cGMP and ISO 13485 requirements. Responsible for testing, sampling, material release and final disposition of product from development through validated processes.

Supervised a team of 23 Inspectors and 2 Leads.

Identified and championed the identification of internal corrective action / preventive action opportunities, identified root causes, and implemented robust corrective/preventive action solutions.

Identified hires and developed QC personnel to meet objectives through mentoring/coaching and training activities, sampling and control strategies, and performance appraisals.

Technical advisor, initiator, and approver of incoming product specifications, FMEAs, validations, deviations, and process and documentation change requests.

Performed internal audits of Quality Management Systems

PLASTIC MOLDED CONCEPTS INC., Eagle WI 08/2013 – 11/2014

Produces several types of straight molded and membrane filtration products used in a wide variety of applications such as oil, water, and air.

Quality Manager

Monitored and managed the company's Quality, and Material Compliance Systems for the Medical, Commercial, Automotive and Military (Lockheed) industry.

Hands on manager active in all facets of the Quality Management System.

Managed a team of 13 Inspectors and 3 Technicians

Defined and championed quality and productions performance metrics for improvement and recommended solutions for top cost of quality contributors. Reduced cost of (poor) quality through continuous improvement methods.

Improved the efficiency, effectiveness, and speed of quality control practices through the identification of robust processes.

Interpreted, evaluated, adapted, and implemented quality assurance standards.

Performed internal audits and championed management reviews to determine the effectiveness and improvement of the Quality Management System.

ADDITIONAL EXPERIENCE

ITW FILTERTEK, Hebron, IL

Designer and supplier of medical, automotive, and industrial filtration components for major original equipment manufacturers, producing custom and standard products from simple components to highly complex devices.

Quality Engineer

Monitored and assured continuing compliance and effectiveness to FDA CFR 820, ISO 13485, 9001, 14001 and TS 16949. Lead ISO 13485, 14001 and TS16949 auditor.

Championed quality and productions performance metrics for improvement and recommended solutions for top cost of quality contributors.

Performed internal and supplier assessment audits of Quality Management System. Served as Lead Auditor and Lead Escort in ISO and customer audits.

Minimized supply chain risk by appraising supplier manufacturing abilities and develop supplier quality systems through on-site visits as part of the supplier management program.

Organized and created submissions to include Process Flow, DFMEA, PFMEA, GR&R, Capability Studies, Control Plans, and Validations.

Active in Advance Product Quality Planning, process improvements, quote reviews, validations, and COQ teams.

Military Experience

UNITED STATES ARMY RESERVE, Milwaukee, WI

19E, M60 Armor Crew Member, Fort McCoy

Rank: Specialist 4; honorable discharge.

UNITED STATES ARMY, Huntsville, AL, Hanau, Germany

27E, Tow and Dragon Anti-Tank Missile Repairman

Rank: Specialist 4; honorable discharge.

Education

Bachelor of Science, magna cum laude, Technical Management, DeVry University, On-Line

Certifications

ISO 9001:2015 Quality Systems Lead Auditor, Calisco Cert # 29850

Six Sigma Green Belt, ITW Filtertek

Certified Lead ISO 13485:2003 Auditor, Calisco Cert # 16151

ASQ CQE (Expired), ASQ Cert # 39824

Professional Development

ISO 9001:2008 Auditor Transition Training

ISO/TS 16949 Internal Auditor Training

ISO/TS 16949:2002 Auditor Guidance Training

Layered Process Audit

FMEA: Potential Failure Mode Effects Analysis

FMEA Reference Manual: Fourth Edition

Production Part Approval Process (PPAP) 4th Edition

Global 8D (G8D) Instructor-led Training

Advanced Product Quality Planning

Continuous Quality Improvement

Production Activity Control

Supplier Certification

Achieve Global Leadership

Team Leadership

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