QT9 Quality Management System
Job Search Status
Open to workDesired start date: Flexible
Open To Work
Tae Banack
Quality Management Systems
Saint Paul,MN
Work Preference
Summary
Quality leader with extensive experience in establishing and scaling Quality Management Systems. Successfully led teams through ISO certification processes, implemented electronic systems to streamline quality operations, and enhanced organizational capacity, resulting in improved operational efficiency and customer satisfaction.
Overview
30
30
years of professional experience
1
1
Certification
Work History
Director of Quality
Advanced Exhaust Solutions, LLC.
01.2024 - 03.2026
- Established and oversaw company-wide Quality Management System (QMS), maintaining compliance with ISO 9001:2015 and enhancing internal outcomes.Led organization through successful ISO 9001 certification and surveillance audit with no findings.
- Implemented electronic Quality Management System (eQMS) using QT9 to digitize and streamline quality processes.
- Scaled quality organization from 2 to 15 members, enhancing Quality Control Inspection, Quality Assurance, and Quality Engineering capabilities.
- Developed structure, processes, and performance metrics to enable rapid organizational growth and ensure compliance.
- Oversaw customer issue resolution through root cause analysis, field service visits, and regular communication, fostering strong customer relationships.
- Interfaced directly with high-level executives within client companies, addressing concerns and correcting perceived faults to maintain smooth customer relationships.
Supplier Quality Manager / Manager, Quality Systems & Standards
Winnebago Industries
Forest City, Iowa
11.2016 - 12.2023
- Led supplier quality team for Winnebago Motorhome division in Forest City, Iowa.
- Oversaw supplier quality functions, including supplier qualification, incoming inspection, NCR/MRB, SCAR issuance, supplier audits, development, and warranty chargebacks.
- Implemented supplier quality processes for incoming inspection, NCR/MRB, CAPA, quality improvement plans, warranty management, performance scorecards, and audits.
- Primary solution architect and configuration expert for Winnebago QMS software system (Intellect) utilized to implement Quality and Business Process Management including Supplier Qualification, Document Management, Corrective Action, Sales Program Requests, Recalls, Audits, and New Product Development.
Quality Manager / Senior Quality Engineer
ATMI / Entegris
02.2011 - 11.2016
- Managed implementation of Quality & Safety Management Software (EtQ Reliance), overseeing software selection, process flow documentation, configuration, validation, and global user training.
- Coordinated team to review and harmonize quality systems globally in preparation for new Quality Management Software (QMS) implementation, including customer complaints, CAPA, SCARs, document control, and internal audits.
- Monitored plant performance and implemented improvements, ensuring compliance with ISO9001 certification.
- Analyzed organizational Quality metrics and facilitated Management Reviews to evaluate results and recommend actions to close gaps at the operational level.
- Project team lead for implementation of new SPC software that included upgrading lab equipment and computers to integrate with new software (camLine).
Senior Quality Engineer / Quality Engineer
Lifecore Biomedical
08.2005 - 02.2011
- Primary responsibilities included performing all aspects of validation studies including master validation plans, protocols, and reports for process, cleaning, facility, equipment, and software validations.
- Conducted gap analysis of US regulations (21 CFR Part 210, 211, 11), EU regulations, USP, and ISO standards (ISO 13485, ISO 14971) to ensure compliance.
- Drafted and revised regulatory documents, including DMFs, for submission in US, Europe, and Japan to support product approvals.
- Updated and reviewed annual risk management assessments per ISO 14971 to maintain regulatory standards.
- Supported new products and product transfers by completing Validation & Verification plans, FMEAs, and control plans.
Vendor Auditor
Paddock Laboratories
09.2003 - 02.2005
- Managed vendor auditing and compliance with GMP210/211 regulations, maintained ASL, performed supplier audits, and enhanced supplier quality documentation.
- Implemented and managed deviation system, training users and tracking deviations to ensure adherence to protocols.
- Developed and administered USP change control system, ensuring compliance with current USP monographs and chapters.
Lab Analyst IV
Pace Analytical
09.2002 - 09.2003
- Responsible for impurity isolation and identification utilizing HPLC analysis from stability and forced degradation studies.
- Recorded and analyzed data to produce reports of results.
- Adhered to laboratory safety procedures to maintain compliance with quality control standards.
Chemist
Quintiles
03.2001 - 07.2002
- Responsible for method development and validation of dissolution methods with HPLC finish.
- Performed dissolution analysis of immediate and extended-release solid oral dosage forms for formulation support, comparative studies, clinical release, and clinical stability studies.
- Used strong analytical and problem-solving skills to develop effective solutions for challenging situations.
Stability Scientist
Oread Laboratories
09.1997 - 03.2001
- Simultaneously managed several complex projects, meeting all pertinent milestones.
- Lead chemist on stability projects that inlcuded HPLC method development and validation, raw material testing, and product release.
- Drafted stability study protocols, scheduling stability time studies, and testing in accordance with ICH guidelines.
Quality Control Technician
Fort Dodge Animal Health
01.1996 - 08.1997
- Responsible for quality control testing of in process, validation, and finished products utilizing analytical techniques such as HPLC, GS, FTIR, UV/Vis, viscosity, dissolution, and other wet chemistry techniques.
- Completed supporting documentation for testing procedures, data capture forms, equipment logbooks and inventory forms.
- Interpreted test results by comparing to established specifications and control limits, making recommendations on appropriateness of data for release.
Education
B.S. - Chemistry
Iowa State University
Ames, IowaSkills
- Quality management and process improvement
- Regulatory compliance and ISO standards
- Performance metrics and quality metrics development
- Strategic planning and six sigma methodologies
- Supplier quality management and quality training programs
- Risk management
- Customer relationship management
- Team leadership and cross-functional collaboration
- Complaint resolution
- Effective communication and problem solving
Certification
Lean Six Sigma Green Belt
Software
Intellect
ETQ Reliance
SAP
Oracle
MS Office: Word, Excel, PowerPoint, Teams, SharePoint, PowerAutomate, Power BI, D365
Timeline
Director of Quality
Advanced Exhaust Solutions, LLC.
01.2024 - 03.2026
Supplier Quality Manager / Manager, Quality Systems & Standards
Winnebago Industries
11.2016 - 12.2023
Quality Manager / Senior Quality Engineer
ATMI / Entegris
02.2011 - 11.2016
Senior Quality Engineer / Quality Engineer
Lifecore Biomedical
08.2005 - 02.2011
Vendor Auditor
Paddock Laboratories
09.2003 - 02.2005
Lab Analyst IV
Pace Analytical
09.2002 - 09.2003
Chemist
Quintiles
03.2001 - 07.2002
Stability Scientist
Oread Laboratories
09.1997 - 03.2001
Quality Control Technician
Fort Dodge Animal Health
01.1996 - 08.1997
B.S. - Chemistry
Iowa State University