Summary
Overview
Work History
Education
Skills
Accomplishments
Certification
Timeline
Generic

DAVID WISEL

Auburn,IN

Summary

An executive with a broad range of experience in QA, QC, Quality Systems, Operations Quality, Supplier Quality, Food Safety, Cosmetic Safety, and FDA compliance across various strictly regulated sectors. A leader adept at developing lean, highly effective quality management systems that meet customer expectations and regulatory standards. This accomplished individual possesses exceptional interpersonal abilities, enhancing team dynamics and fostering the development of team members' performance across multiple sites. The array of tools employed for continuous improvement encompasses lean sigma, various lean manufacturing techniques, operational excellence strategies, risk assessment and a thorough audit program aligned with the organization's strategic goals to minimize variation and boost profitability.

Overview

27
27
years of professional experience
1
1
Certification

Work History

Director

Kuraray
11.2020 - 08.2024
  • Managed the Quality Management System for ten international sites in the US, UK, Europe, Japan, and Poland, ensuring compliance with ISO 9001, RC 14001, ISO 14001, FDA, Kosher, Halal, EFFCI, HACCP, SQF, and other standards
  • Directed a team of over 40 quality professionals, including Associate Directors, Managers, Engineers, Coordinators, Lab Technicians
  • Reduced PPM defect rate from 10,000 to 2,500 within 18 months and the establishment of a comprehensive VOC program
  • Maintained QA and QC budgets for each MonoSol location and measured cost of quality
  • Employed project management skills to guide a cross-functional team in selecting and implementing a new Electronic Quality Management System (EQMS). The project was completed on schedule and within budget. The new EQMS includes an electronic document management system, change control, calibration recall, customer complaints, CAPA as well as a Learning Management System (LMS) database
  • Conducted extensive risk review activities to direct Six Sigma and Lean Sigma initiatives, certifying over 20 green and black belts, which resulted in a savings of over $800,000 in 2023
  • Trained on FDA regulations, food & cosmetic safety, problem-solving techniques, good documentation practices, & ISO 9001 standards
  • In collaboration with Process Engineering and Operations, developed a detailed process control strategy. Statistical Process Control SPC is now fully implemented in the testing facilities, and data collection systems are in place for the "global lead lines" at each site
  • Led the LEP Loss Elimination Program team to assess risk and create projects aimed at saving costs, minimizing variation, and fostering continuous improvement. The efforts resulted in savings exceeding $1,000,000 across 12 projects in 2023
  • Initiated a process validation strategy encompassing IQ/OQ/PQ and software validations
  • Aligned test laboratory practices globally and reduced test variation GR&R/MSA and round-robin testing to improve GLP practices
  • Led an international audit team that performs internal and supplier audits. Utilizing an integrated management system audit approach to evaluate Quality, GLP Lab controls, EHS&S, as well as food, cosmetic, sustainability, and good documentation practices
  • Revamped supplier quality management program to enhance the evaluation of suppliers and boost their performance. This effort resulted in a new supplier audit program that assesses risk, introduces a three-tier assessment system, and establishes a supplier portal for feedback and COA documentation management.

VP

Taylor Made, LCI
07.2015 - 11.2020
  • Responsible for the Quality Assurance (QA) and Regulatory Affairs (RA) across 15 sites. This included designing, implementing, and maintaining the Quality Management System (QMS) to comply with industry standards and regulations, such as ISO 9001, IATF 16949, and AS9100, for various vehicle applications.
  • Maintained QA and QC budgets for each Taylor Made location and measured cost of quality
  • Developed quality standards and developed a "Taylor Select" product line to meet the needs of our most discerning customer applications.
  • Directed a cross-functional team in developing a customer complaint application that has been adopted company-wide and is utilized by all customers today. This initiative has improved customer satisfaction and led to the organization reaching an all-time low in PPM performance.
  • Led the internal audit team and served as management representative across all sites, resulting in superior audits and achieving 100% compliance with on-time audits.
  • Improved the supplier evaluation process and created a performance monitoring feedback system for our suppliers to enhance communication.
  • Led and developed a team comprising quality managers, coordinators, technicians, and engineers, which included implementing a career track activity and succession planning
  • Provided classroom and on-the-job training on Statistical Methods, Laboratory Techniques, Safety Procedures, ISO 9001 Standards, Quality requirements, risk assessment tools and Industry Best Practices
  • Employed project management skills to guide a cross-functional team in selecting and implementing a new Electronic Quality Management System (EQMS). The project was completed on schedule and within budget and included an electronic document management system, change control, customer complaints, CAPA as well as the Learning Management System (LMS) database
  • Achieved consistent improvement in key performance indicators, including a 50% decrease in parts per million defects, resulting in a 25% reduction in the total cost of quality.
  • Enhanced employee engagement and satisfaction through the implementation of comprehensive training programs and performance management systems

Corporate Quality Systems Manager

Paragon Medical
11.2010 - 07.2015
  • Managed the quality system across seven domestic and international sites, ensuring adherence to cGMP, FDA 21 CFR Part 820, CE marking, and ISO 13485 standards
  • Served as ISO 13485 Management Representative and provided front room support during FDA QSR inspections at all locations
  • The company had zero FDA 483 warning letters and improved compliance during each third-party audit
  • Led quality assurance initiatives and cultivated the skills of team members across the US, Europe, and China. This included, training each Quality Manager to ensure uniformity across the organization
  • Maintained CAPEX, QA and QC budgets for each Paragon location and measured cost of quality
  • Managed 510(k) submissions, streamlined the technical file process, and registered all medical devices with the FDA, including the UDI (Unique Device Identification)
  • Employed project management skills to guide a cross-functional team in selecting and implementing a new Electronic Quality Management System (EQMS)
  • The project was completed on schedule and within budget and included an electronic document management system for managing quality system documents, prints, and specifications, as well as the Learning Management System (LMS) database
  • Led the global internal audit team of 18 ISO 13485 Lead Assessors and 15 internal auditors, ensuring 100% compliance with timing requirements
  • Revised the supplier quality manual, enhanced supplier metrics, and performed numerous audits for supplier development.
  • Ensured compliance with GD&T for Class I through III implantable medical devices, instruments, and sterilization containers
  • Led validation processes for more than 300 machines and software applications, overseeing the organization's Master Validation Plan
  • Played a crucial role in the team responsible for launching two facilities in China and one in Poland, ensuring each site was opened on schedule with a fully trained staff.

Quality Manager

Smiths Medical
11.2008 - 11.2010
  • Led the quality system at two locations in accordance with 21 CFR part 820, cGMP, and ISO 13485 requirements
  • Managed the quality budget for each facility
  • Successfully led the organization through an FDA remediation activity in under six months, addressing each 483
  • Oversaw the quality system, including leading front room activities during FDA QSR inspections
  • Ensured regulatory compliance with the FDA and international bodies such as Health Canada, Japan, Australia, and the European Union, including obtaining the CE mark
  • Played a key role in numerous 510k submissions, from concept to post-market surveillance completing five new submissions in one year
  • Oversees biological aspects of clean rooms and manages external sterilization contractors.

Division Quality Manager

Gold Shield, Fleetwood Industries
04.1997 - 01.2008

Education

Bachelor of Science - Business Management

Bellevue University
Bellevue, NE

MBA -

University of Arizona
Tucson, AZ

Master of Science - Quality Assurance

California State University - Dominguez Hills
Carson, CA

Skills

  • Rapid QMS implementation and upgrades
  • NPD & product launch including APQP & PPAP
  • Process Validation IQ/OQ/PQ & software
  • Leadership and cross functional team building
  • ISO 9001, ISO 13485, IATF 16949, AS9100
  • CGMP, GMP, 21 CFR part 11, GxP, GCP, GLP
  • Quality awareness and recognition programs
  • Toyota Production system, Kaizen, GEMBA, 5s
  • Cost of quality, price of nonconformance control
  • Zero defect programs & PPM defect reduction
  • MSA, Control plan, PFMEA, DFMEA
  • Operational excellence, CI programs
  • Strategic planning & project management
  • Internal & supplier audit leadership
  • HACCP, GFSI, FSPCA SQF, FSQA, FDA
  • Statistical Process Control implementation
  • Chemical and testing lab testing oversight
  • Electronic Quality Management Software
  • Scrap & rework reduction programs
  • Change management & control ECN/ECR
  • Supplier development & tracking
  • TQM and self-directed work teams
  • Classroom and one on one training
  • Six Sigma & Lean Sigma leadership
  • 510k submission and oversight
  • Extensive multi-site experience
  • EFfCI, ISO 27001 cosmetic standards
  • 8d, CAPA problem solving, risk assessment
  • KPI and dashboard implementation
  • EHS compliance ISO 14001, RC 14001

Accomplishments

  • University educator and corporate trainer, courses including SPC, ISO 9001, internal quality system auditing
  • Involved in an advisory committee for Grace College - Orthopedic Regulatory and Clinical Affairs (ORCA)
  • Involved in a collegiate advisory committee for Ivy Tech State College - Pre-Engineering program
  • ISO 22000, FSSC 22000, HACCP, Food safety plan, FDA, FSPCA preventative controls / food defense & security, PCQI, FSS / USDA, SQF, BRC, FSMS, SSOP Hygiene, cleaning, sanitization, FSMA, FSQA, Pest Control, Foreign Material Control
  • EFfCI, ISO 27001, FDA, EFfCI, ISO 27001, cGMP & GMP, CFR labeling directives, product recall, crisis management plan
  • Sustainability activities, plastics reduction, packaging, waste elimination and multiple additional programs implemented
  • Various trainings on process control, including advanced levels of Statistical process Control and Minitab training
  • Extensive training in the Toyota production system including all aspects of lean manufacturing, lean sigma, Kaizen and CI
  • AIAG training APQP, Control Plans, PFMEA, DFMEA, Gage R&R / MSA, PPAP, Problem solving and Change Management

Certification

ASQ certification exams (CMQ/OE) Manager of Quality and Organizational Excellence, (CQA) Auditor & (CQT) technician

Timeline

Director

Kuraray
11.2020 - 08.2024

VP

Taylor Made, LCI
07.2015 - 11.2020

Corporate Quality Systems Manager

Paragon Medical
11.2010 - 07.2015

Quality Manager

Smiths Medical
11.2008 - 11.2010

Division Quality Manager

Gold Shield, Fleetwood Industries
04.1997 - 01.2008

Bachelor of Science - Business Management

Bellevue University

MBA -

University of Arizona

Master of Science - Quality Assurance

California State University - Dominguez Hills

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DAVID WISEL