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Quality Engineer Manager

Location:
Apollo Beach, Florida, 33572, United States
Posted:
August 26, 2018

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Resume:

CHUCK UNDERWOOD

ASQ SIX SIGMA BLACK BELT, CMQ/OE, CQE, CQA

**** ********** *****,****** ***** FL. 33572

Cell: 813-***-**** Email: ac6tgg@r.postjobfree.com

Professional Summary

A hard-working Quality and Regulatory management professional with over 20 years of experience that can lead an organization to meet their goals of establishing a global Quality Management System. Initiatives such as ISO implementation (start-up or existing), reduction in cost of poor quality, and stream line processes are some of my proudest accomplishments. I am data and results driven while maintaining relationships built and centered on trust and integrity. My approach is one of a sales and process enabler not a sales and process disabler by working within the Quality Management System while maintaining compliance to either Regulatory and/or International Standards. I enjoy and welcome the challenge to get people on the same page in regards to what a Quality System can do for them and to show others how you can control a Quality System without the Quality System controlling you. A Quality and Regulatory professional that can lead and champion process-improvement initiatives - everywhere from small business to multinational corporations - that can have regional or global focus in a variety of service and industrial settings. Working experience in Medical Device, Pharmaceutical, Automotive and Appliance Industry.

Core Qualifications

Strong Decision Maker Customer Focused

Excellent Communicator and Facilitator Proficient in statistical and process analyzes

Experienced in Problem Solving Techniques Leadership Qualities

Certified Lean Six Sigma Black Belt Extensive Global Program Management Experience

Strong QA Process Efficiency Expertise Voice of the Customer (VOC)

Excellent Interpersonal Skills Strong Team Building Skills

Extensive Medical Device Industry Experience Excellent Multi-Tasking Experience

Experience

Cardinal Health PR - Formerly Medtronic

Minimally Invasive Therapies

Quality Systems Manager- June 2016 - Present

Tampa, Florida

Medical Devices: Compression Sleeves, Lead Wires, and Oxygen Sensors

Achieved MDSAP certification within 18 months of employment.

Achieved ISO 13485 certification in 8 months.

Reduced cost of poor Quality by 50% from previous year.

Streamed line inspection process by focusing on voice of the customer and separating critical characteristics from non-value-added reviews

Directs team of Quality Engineers and Technicians by removing roadblocks to help team members meet their projects goals and timelines

Guide team members in career path and growth to help them reach their full potential

Responsible for supplier audits, performance and incoming inspection

Builds strategic partnerships to further QA organizational objectives and collaborates with all levels in developing strategic direction for short and long-term business planning

Proactively provides leadership in Quality with focus on developing and deploying effective prevention, corrective action and continuous improvement programs and using Six Sigma and Lean tools/programs

Oversees failure investigations and make recommendations for the appropriate quality and business strategy

Ensures that Quality Systems and organizations are efficient and effective and are utilized in a proactive manner to deliver competitive advantage and are relevant to the business needs and compliant with all regulatory requirements

Identifies and analyses quality trends and proposes and implements strategies and projects to maximize and optimize overall quality performance

Provides technical expertise and support measurement systems, Six Sigma, ISO based Quality System design, analytical problem solving through sound statistical application

Provide leadership and vision with a focus on prevention, continuous improvement and customer satisfaction

Counsels technical and business groups to ensure that product transfers are conducted in a timely manner with no negative impact to either product quality or service

Ensures the business is in a constant state of readiness for regulatory inspections.

ABT Molecular Imaging

Director of Regulatory Affairs and Quality Assurance- March 2015 - June 2016

Knoxville, TN

Pet Biomarker and Radioisotope Manufacturer - Start-up Company

Created turn-key Quality Management documentation system for new suppliers

Streamline NCR process from months to days for closure

Created cost savings initiative to reduce the viable and non-viable studies based on past data.

Drove all drug regulatory knowledge and strategy to the organization ensuring understanding and adherence to target region PET drug regulations and licensing requirements - emphasis on US FDA, EU and US Pharmacopoeia, ANDA and GMP requirements.

Quality management representative and the primary project manager/leader maintaining the implementation and compliance of our quality management system to ISO 13485 and 9001 device manufacturing standards.

Directed and continually improve all Regulatory Affairs and Quality Assurance control activities, programs and policies - Enhanced and maintained knowledge of PET industry specific to EU and US Pharmacopoeia and GMP requirements. Communicate appropriate application of requirements internally for product roadmap and design considerations.

Managed external consultant resources and project plan toward a 18F FDG PET ANDA filing including submission of a Drug Master File (DMF).

Regulatory representative on project teams providing regulatory input and strategy; interacting with global target market regional Regulatory Authorities on assigned projects as appropriate.

Maintained ISO 8 Clean Room certification for sterile products.

ProNova Solutions

Quality Assurance And Regulatory Affairs- October 2013 - March 2015

Knoxville, TN

Proton Therapy Manufacture (FDA Regulated) – Start-up Company

Created Quality Management System that is in compliance with QSR, MDD, ISO 13485, ISO 9001, and other applicable regulations and standards pertaining to a Type II Medical Device

Managed, directed, developed and evaluated a competent workforce

Created Processes, Procedures, and Work Instructions thru Cross functional teams

Managed project timelines and budget to ensure high quality and timely delivery of product

Worked with Cross functional teams to develop an expertise in interpretation and pragmatic application of Quality Standards

Initiated Innovative approach to Quality Solutions and applications in a start-up environment

Siemens Medical Solutions

Operations Quality Assurance Manager- June 2006 – October 2013

Knoxville, TN

Scanners, Cyclotrons, Detectors Manufacture (FDA Regulated)

Managed staff of engineers and technicians.

Reduced cost of poor Quality by 50% in two years by leading cross functional teams thru DMAIC approach.

Blackbelt projects such as reduction of calibration interval times and reduction of amplifier complaints resulted in $27,000 annual cost savings and double to single digit complaints respectively

Spearheaded Supply Chain Management group in regards to Quality initiatives and new/minor product changes.

Established critical partnerships with suppliers by establishing supplier monthly feedback report thru the use of poor cost of Quality.

Enhanced Siemens local procedures by defining work flows, jobs, and reporting relationships to obtain optimum effectiveness.

Developed departmental budgets and business plans for functional area.

Identified resource needs and developed justification to meet those needs.

Drove process measurement initiatives, including scorecards and other metrics, which was used to drive process improvements.

Chaired and participated on several teams that focused on voice of the customer and customer concerns.

Established supplier auditing system format and executed those supplier audits.

Denso Manufacturing

Quality Engineer- April 2004 – June 2006

Maryville, TN

Staff Engineer – Starters/Alternators Manufacture

Analyzed and investigated customer and warranty returns to determine the root cause of failure mode. Upon investigation, issues Technical reports to the customer explaining failure mode, countermeasures, and implementation plans

Ensured Quality of new products by developing test plans, analyzing results, issuing required documents to customers, planning quality schedules, and conducting and arranging customer visits.

Liaison between customer (Honda, Chrysler, General Motors) and Denso quality manufacturing.

Internal auditor for QS 9000 and TS 16949 program.

Nissan North America- Smyrna, TN

Quality Engineer- May 2002 – April 2004

Body/Stamping- Automotive Manufacture

Project Engineer for Product Assurance in the Body/Stamping Plant

Approved tooling, gauges, and part modifications on behalf of Product Assurance

Liaison between design intent and manufacturing capability

Generated Inspection Standards, Set-up Gauge Sheets, and R&R reports

Oversaw stamping of project vehicles from build to launch on behalf of Product Assurance

Finished Bachelors Degree from the University of Tennessee 2000-2002

Certifications

American Society of Quality: Certified Six Sigma Black Belt (15446), Certified Quality Manager (15980), Certified Quality Engineer (53668), Certified Biomedical Auditor (806)

Education

University of Tennessee- Bachelor of Science Mechanical Engineering May 2002

Pellissippi State Community College - Associate of Science Mechanical Engineering, May 2000

Pellissippi State Community College - Associate of Applied Science Computer Drafting May 97



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