Donald G. Wallace, Jr.
Mentor,OH
Summary
35+ years of success leading quality management initiatives in multiple industries, including electronics, medical devices, nuclear, aerospace, manufacturing and automotive. Multi-skilled quality management professional with repeated accomplishments driving continuous quality improvement, developing, monitoring, and presenting internal quality measures and initiatives to improve organizational performance. Expertise in project management, operations improvement, risk management, and supplier development. Proven track record as management representative for ISO-9000, ISO 13485, FDA, IATF16949, AS9100, NADCAP, ITAR, and ISO14001 and ISO 45001. Equally capable of building and managing high-performing quality assurance teams or working independently to enhance performance, boost competitive advantage, and increase bottom-line gains. Engaging businessperson; able to forge solid relationships with key internal and external stakeholders and build consensus across multiple organizational levels.
Overview
20
20
years of professional experience
Work History
Quality Manager
TT Electronics
Perry, Ohio
06.2023 - Current
- Company Overview: Electronic Contract Board Manufacture
- Quality Leader of a team of 20+; Quality Engineers, Quality Technicians, Final Inspectors, Test Engineers, Quality System Engineer, Training & Trade Compliance and Training Coordinator
- Lead FDA Audits for Class 1,2,3 devices
- Ensure cGMP compliance and identify and ensure compliance with domestic and international regulations, standards, and guidelines (ISO 13485, 21 CFR 820, MDD 93/42/EEC)
- Lead ISO 13485, ISO 14001, ISO 45001, AS9100, TUV, and UL audits
- Reduced nonconforming product by 75%
- Updated QMS procedures to the requirements of 21 Part 820 /ISO 13485
- Trained staff in PFMEA, Risk Management, and validations
- Electronic Contract Board Manufacture
Director of Quality / Regulatory Affairs
COAX Technology, Inc
Solon, Ohio
04.2022 - 06.2023
- Company Overview: Electronic Contract Board Manufacture
- Hired to fix a broken Quality Management System
- Provided a clear path to revamp ISO 9001, and ISO 13485, systems that was in immediate attention
- Establish certification in AS9100 and NADCAP
- Lead FDA Audits for Class 1,2,3 devices
- Ensure cGMP compliance and identify and ensure compliance with domestic and international regulations, standards, and guidelines (ISO 13485, 21 CFR 820, MDD 93/42/EEC)
- Designated as the Management representative for ISO and other certifications
- Provided expertise to product development and operations in statistical data analysis when creating Design history files and Device Master records
- Lead the customer complaint and feedback system
- Establish and drive corrective actions plans and investigations, CAPA (Corrective and Preventive Actions), nonconforming product (MRB- Material Review Board), and verification of effectiveness of the root cause and corrective action to eliminated repeat issues
- Corrected 30+ procedures and work instructions to meet the requirements of ISO 9001, ISO 13485, and FDA 21 Part 820
- Trained staff in PFMEA, Risk Management, and validations
- Responsible for Health, safety and environmental programs create a safe workplace
- Worked with the president and director of operations to ensure OSHA and EHS comply to our policies
- Improved Customer Satisfaction from 85% to 98% goal
- Lead major projects for scrap reduction, new product introduction and Engineering Change notices
- Closed 60 actions items associated with (4 majors/16 minors) from a Failed Audit
- Passed a successful audit in December 2022, closing all action items within 7 months
- Added new requirements into new procedures for AS9100 and trained staff and employees to the new certification
- Implement new requirements AS9100D and NADCAP implementation, ready for certification through Smithers registration
- Re-established the internal audit program to meet all the requirements for all current standards
- Created and implemented Master Validation Plans and Protocols for all equipment
- Educated and trained the Senior staff and employees in quality and the requirements associated with the cost of quality
- Implement new software to drive the Quality Management System
- Reorganized the Quality Department and hired key staff members
- Electronic Contract Board Manufacture
Director of Quality / Regulatory Affairs
Valtronic Technology
Solon, Ohio
06.2018 - 04.2022
- Company Overview: Electronic Contract Board Manufacture
- Hired to fix a broken Quality Management System
- Drive all aspects of quality engineering, assurance, and control
- Provide regulatory guidance to project teams for design, development, and commercialization of medical devices, reviewing and approving documentation for regulatory compliance
- Conduct management reviews of quality system, ensuring accuracy and compliance with ISO 13485:2016 and FDA 21 Part 820 requirements
- Play key role in third-party audits (FDA, Notified Body) of Quality Management System, serving as Quality Management Leader for FDA visits
- Build and develop quality assurance teams
- Provide leadership for International Medical Device Regulators Forum (IMDRF) and the Global Harmonization Task Force (GHTF) for our Switzerland and Morocco facilities
- Conducted organization-wide training in FDA Regulations FDA 21 Part 820 Quality System Regulations
- Established certification for ISO/IEC 80079-34 Quality Management System for explosive product
- Electronic Contract Board Manufacture
Director of Quality
Soundwich Inc.
Cleveland, OH
01.2017 - 06.2018
- Company Overview: Automotive stamping manufacturing
- Managed Quality Management System for automotive stamping manufacturing from TS16949 to IAFT16949, achieving certification
- As Management Representative for IATF 16949/ISO 14001 and Safety Compliance, ensured adherence of manufacturing processes to regulatory requirements
- Monitored and managed Environmental Quality System from ISO 140001:2004 to 2015, training senior management to new IATF standard; achieved compliance and certification
- Led process improvements, reducing open corrective actions from 100 to total of four by adding error-proofing methods to process
- Moved TS16949 to IATF 16949 one year ahead of schedule; second company domestically to complete
- Automotive stamping manufacturing
Manager--Complaint Investigation
VWR International, Inc.
Solon, OH
01.2016 - 12.2016
- Company Overview: Medical manufacturing company
- Managed four-member team investigating customer complaints within enterprise quality management system for medical manufacturing company
- Served as Management Representative for FDA and ISO 13485 audits
- Led implementation of Material Review Board (MRB) to reduce scrap and investigate quarantine product dispositions
- Boosted product quality and compliance with good manufacturing practices by introducing inspection audit plan
- Trained all investigators in Root Cause Analysis and Failure Mode and Effects Analysis (FMEA)
- Played key role in FDA audits, passing audits by adherence to good manufacturing processes
- Medical manufacturing company
Quality Assurance Manager
Thermo Fisher Scientific
Oakwood Village, OH
03.2014 - 12.2015
- Company Overview: Design, Development and Manufacture of medical devices
- Served as Management Representative for ISO 13485:2003, FDA 21 Part 820 Quality System Regulations, IVDD, and Canadian Medical Device SOR 98-282
- Prepared and submitted device experience reports in accordance with FDA Medical Device Reporting System regulations
- Conducted root cause analysis to investigate customer complaints and issued Corrective Action Preventive Action (CAPA) plans based on data analysis, improving customer satisfaction ratings
- Drove monthly metric performance for Practical Process Improvement (PPI) Business System
- Managed projects from inception to completion, developing schedules to ensure timeframes and quality controls were met
- Drove recovery plan for design transfer, meeting Design History File requirements to ISO 14971, IEC 62304 and IVDD
- Spearheaded implementation of new design control standard operating procedure (SOP) companywide, including Master Control for SOPs and FDA-required documents
- Developed Global Harmonization Metrics for all locations and implemented new tracking system for Quality Management System
- Design, Development and Manufacture of medical devices
Quality Manager
Norman Noble, Inc.
Highland Hts., OH
01.2011 - 09.2013
- Company Overview: Micro-precision contract manufacturing of medical implants and devices
- Served as Management Representative for ISO 9001, ISO 13485:2003 and FDA 21 Part 820 Quality System Regulations
- Conducted final inspections for micro-precision contract manufacturing of medical implants and devices, overseeing 40 direct reports in two plants
- Cross-trained inspectors and organized improved processes, planning new floor layout to improve efficiencies
- Streamlined operations, improving product shipping efficiencies from 75% to 94%
- Led implementation of final report database, reducing error rates by inspectors on final reports prepared for customers
- Oversaw purchase of two new pieces of inspection equipment totaling $350K with return on investment in less than six months
- Micro-precision contract manufacturing of medical implants and devices
Quality Manager
Astro Medical Devices
Mentor, OH
04.2009 - 01.2011
- Company Overview: Micro-precision contract manufacturing of medical implants and devices
- Served as Management Representative for ISO 9001, ISO 13485:2003 and FDA 21 Part 820 Quality System Regulations
- Managed quality control for micro-precision contract manufacturing of medical implants and devices, earning Top Supplier Award from military client for superior quality and delivery by implementing effective lean manufacturing strategies (including Kaizen events)
- Conducted training for key processes, Kaizen events, and proper use of calibrated measuring equipment
- Designed, developed, and implemented new site assessment supplier quality audit plus scorecards
- Drove improvements to external audits, implementing Quality System Navigator for Quality System Management
- Acted as project manager for new product launch for new $2M customer
- Established and implemented new processes for contract review, project planning, change management, and verifying effectiveness of CAPAs
- Micro-precision contract manufacturing of medical implants and devices
Supplier Quality Assurance Engineer
Lincoln Electric Company
Cleveland, OH
08.2006 - 04.2009
- Company Overview: Design, Development and Manufacture of welding products
- Established and implemented new processes for contract review, project planning, change management, and verifying effectiveness of CAPAs
- Manage (3) employees: (1) incoming inspection (2) CMM support
- Created and implemented a new Site Assessment Supplier Quality Audit and performed training in our Shanghai, China Factory
- Travel to China ~25%
- Created/ Implemented/ Trained ~90 employees in a new PPAP process
- (Production Parts Approval Process)
- Performed numerous audits using the new supplier assessment process for evaluating new, current suppliers and identifying opportunities for improvements for both domestic and international suppliers
- Project Leader on a major project: Designed and built a new Lab to house a new Brown and Sharpe CMM
- Project came in $9K under budget
- Involved in the reduction of the RTS area for Nonconforming material and helped create a weekly metric
- Involved in implementing a supplier scorecard
- Assisted in creating the form for the measurable
- Assign incoming test plans for new suppliers
- Support Engineering when new costs saving opportunities
- Interface with Supply Management, Production, Accounting, Engineering and External suppliers when required for corrective actions
- Design, Development and Manufacture of welding products
Quality Manager
Libra Industries Inc.
Mentor, Ohio
09.2004 - 07.2006
- Company Overview: Electronic Contract Board Manufacture –ISO-9001/ISO 13485
- Management Representative for the Quality Management System for ISO 9001: 2000
- Established certification for ISO 13485:2003 medical devices
- Instrumental in creating an internal internet site for each department to promote internal communications and paperless system
- Created and implemented a new Access database for Corrective/Preventive Actions and Internal Audits
- Created and implemented Customer Satisfaction Scorecard performance system to assure that our client has the perception
- Electronic Contract Board Manufacture –ISO-9001/ISO 13485
Education
Bachelor of Science - Electronic Engineering
Electronic Institute of Technology
Cleveland, OhioSkills
- Strategic & Tactical Planning
- Process Improvement
- Supplier Development
- Change Management
- Risk Management
- Six Sigma Methodologies
- Project Management
- Internal/External Audits
- Stakeholder Engagement
- Product Development
- Statistical Analysis
- Team Building & Leadership
- Continuous Improvement
- Performance monitoring
- Quality Management Systems
- Operational Excellence
- Validation management
- Corrective Actions
- Internal Auditing
- Regulatory Compliance
- Statistical process control
- First-Article Inspection
- Operation Monitoring
- Supplier quality management
- Document Management
- Management Consulting
- Quality processes
- Problem-solving abilities
- Document Control
- External audit support
- Supplier Relationship Management
- Total Quality Management
- Customer Satisfaction
- Market research experience
- Operational Improvements
- Excellent researching skills
- SOP review
- Team Training
- SOP Development
- Statistical analysis skills
Training
- Six Sigma Black Belt
- Baldridge Assessor
- Training & Development
- Quality Driven Leadership (QDL)
- Microsoft Word/Excel, Access, PowerPoint, and Visio
- Total Quality Management (TQM)
- Internal/External Auditing
- SAP ERP System and Plex ERP Systems
- ITAR - International Traffic in Arms Regulation
- Risk Management and Software Life Cycle
- FDA Training to Part 820 Quality System Regulations
- Project Management
- Minitab, Statistical Analysis
- Process Mapping, Benchmarking
- Customer Satisfaction Process
- Microbiological Training
- Failure Mode and Effects Analysis
- PMEA
- Problem Solving
Timeline
Quality Manager
TT Electronics
06.2023 - Current
Director of Quality / Regulatory Affairs
COAX Technology, Inc
04.2022 - 06.2023
Director of Quality / Regulatory Affairs
Valtronic Technology
06.2018 - 04.2022
Director of Quality
Soundwich Inc.
01.2017 - 06.2018
Manager--Complaint Investigation
VWR International, Inc.
01.2016 - 12.2016
Quality Assurance Manager
Thermo Fisher Scientific
03.2014 - 12.2015
Quality Manager
Norman Noble, Inc.
01.2011 - 09.2013
Quality Manager
Astro Medical Devices
04.2009 - 01.2011
Supplier Quality Assurance Engineer
Lincoln Electric Company
08.2006 - 04.2009
Quality Manager
Libra Industries Inc.
09.2004 - 07.2006
Bachelor of Science - Electronic Engineering
Electronic Institute of Technology
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