CYNTHIA FUNKHOUSER
Hamilton,OH.
Summary
Quality Assurance Manager proficient in all QA operations, policies and procedures. Experience hiring and developing individual team members. Committed to thoroughly assessing product quality and manufacturing processes to achieve excellent results and customer satisfaction.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Quality Assurance Manager – Certified Lead Auditor
Renegade Materials Corp
Miamisburg, OH
05.2020 - 01.2022
- Maintain ISO 9001, AS9100, and Nadcap certifications
- Conducted root cause analysis via 5 Why / 8 D development of corrective action plans
- Ensure effectiveness of RCCA
- COTO: Interested Parties, Risk, & Opportunity Registers
- Drive Continuous Improvement
- Leadership for Quality, and Support Production
- Internal Lead Auditor / Scheduled and conducted internal audits and supplier approval audits
- Acclimated Employee Quality training
- Oversee all aspects of Quality Management System (QMS), Quality Objectives and KPIs
- Monitor Trends for Customer Satisfaction, On-Time Delivery, and External Providers performance
- Document Control
- Internal Auditing Team
- Communicate with President on Quality Status
- Collaborated with audit clients and action owners to apply root cause analysis guidance and establish effective corrective action plans.
- Tracked quality issues with external customers, suppliers and internal plant operations.
- Applied coaching techniques and tools to support managers and team members in improving performance.
- Established and tracked quality department goals and objectives.
- Scheduled and chaired quality review meetings to review effectiveness of performance mitigating risk, improving throughput and achieving customer satisfaction.
- Implemented new quality assurance standards.
- Monitored staff organization and suggested improvements to daily functionality.
- Cooperated with engineering and manufacturing and to verify adherence to quality standards.
Quality & Safety Manager – Certified Lead Auditor
MENDENHALL TECHNICAL SERVICES, INC
Cincinnati, OH
04.2019 - 01.2020
- Inspected outbound shipments and conducted random sampling of product quality.
- Worked with specific production team members to rectify production issues and maintain high-quality final products.
- Supervised production workers to identify areas in need of improvement for high-quality production.
- Routinely checked measuring equipment to resolve testing problems.
- Performed preliminary, in progress, hidden damage and final product inspections.
- Maintained high standard of workmanship by using only approved data, materials, tools and test equipment.
- Performed frequent visual inspections to root out tolerance and compliance issues.
- Liaised between production and quality assurance departments to streamline processes and increase daily productivity.
- Documented findings and produced reports to aide management in assessing and correcting quality concerns.
Corporate ISO Manager
LSI Industries
Cincinnati, OH
10.2018 - 04.2019
- Maintain ISO 9001;2015 registration of quality system through annual surveillance audits by registrar Quality, HR, and Production guidance and support
- Review Pilot Runs for new engineered production parts
- Daily review of PPM, Reject rates, and Continuous Improvement projects
- Attend frequent Kaizen and daily Gemba walks, FIFO inventory
- Updated ISO 9001, procedures, work instructions, inspection.
- Monitored staff organization and suggested improvements to daily functionality.
- Collaborated with audit clients and action owners to apply root cause analysis guidance and establish effective corrective action plans.
- Implemented ISO 9000 quality systems, defining business practices, leading to certification and better business practices.
- Implemented new quality assurance standards.
- Developed quality planning for multiple new product launches by verifying customer requirements and implementing in design and production.
- Determined quality department standards, practices and procedures.
- Tracked quality issues with external customers, suppliers and internal plant operations.
- Established and tracked quality department goals and objectives.
Quality Manager
Exact Metrology Inc.
Cincinnati, OH
09.2017 - 10.2018
- Maintained ISO 9001, IATF 16949, ITAR, FAA
- Directed all quality activities at company's multiple sites
- Reviewed and updated ISO 9001, procedures, work instructions, inspection
- Drive Production 5s/ 6s program
- Worked with all departments to develop and implement corrective action
- Facilitated weekly Company business, Corrective Action, and KPI meetings with Management
- Facilitated Employee ISO 9001 training
- Updated quality control standards, methods and procedures to meet compliance requirements.
- Followed quality standards and procedures to minimize errors and maximize customer satisfaction.
- Evaluated quality problems and performed assessments to identify and resolve issues.
- Equipped and organized facility to comply with company strategy for online and offline quality controls.
- Wrote and implemented new rework procedures to standardize processes and streamline workflow.
- Managed and archived quality documentation and participated in internal and external quality audits.
- Mentored and encouraged employees to strive for excellence while fostering professional growth.
- Developed and deployed production control plans and created work instructions and procedures.
- Maintained calibrated instruments in service area and quality lab.
- Liaised with HR manager to organize and perform quality standard training for new and existing staff.
Quality Manager
Newman Sanitary Gasket
Lebanon, OH.
02.2015 - 09.2017
- Interpreted pharmaceutical requirements and utilized careful judgment to determine compliance
- Ensured Clean Room compliance
- Investigated non-conformances, and independently resolved issue, or interfaced with technicians and engineers to diagnose and remedy problem
- Managed team of Quality Technicians
- Managed pest control and sanitation
- Drive Continuous Improvement
- Ensured compliance with strict cGMP requirements through constant monitoring of safety and housekeeping activities
- Conduct FAI, Fist Piece, and SPC inspections
- Audited batch records from previously conducted studies for completeness and compliance
- High degree of customer and vendor contact
- Scheduled and conducted internal audits and supplier audits
- Cooperated with engineering, manufacturing and corporate accounting to verify adherence to quality standards.
- Evaluated suitability of business and technical processes and procedures and recommended improvements to comply with updated operations guidelines.
- Reported production malfunctions to managers and production supervisors.
- Maintained quality system documentation and updated specific documents to reflect new audit or test results.
- Worked with users to maintain accurate quality records and supporting materials to document quality-related activities.
- Monitored staff organization and suggested improvements to daily functionality.
- Inspected products and worker progress throughout production.
- Implemented new quality assurance standards.
- Prepared and collection production reports.
- Advised management of quality audit non-compliance issues to facilitate improved audit compliance rates.
- Collaborated with internal subject matter experts to perform data reconciliations and produce credible results.
- Monitored active and inactive department rosters and updated database to reflect employee additions and deletions.
- Scheduled and managed internal and supplier-based audits to verify compliance with document control procedures.
- Specified quality requirements of raw materials with suppliers.
- Tracked corrective action reports and confirmed closure of corrective action requests to demonstrate adherence to quality standards.
- Participated in targeted customer audit initiatives and produced required documentation to support verifiable results.
Quality Assurance Specialist
Phoenix Technologies/ AK Steel
Middletown, OH
12.2011 - 01.2015
- Leadership
- Project Management guidance and support
- Haired monthly safety meetings while driving safety training and maintenance of OSHA compliance reporting
- Maintain AS9100 ISO 9001 registration of quality system through annual surveillance audits by registrar
- Drive company’s Continuous Improvement program
- Conducted root cause analysis via 5 Why and development of corrective action plans
- Monitored and measured effectiveness of RCCA
- Development of Control Plans and Failure Mode and Effects Analysis (FMEA)
- Tracked critical spares inventory
- Scheduled and conducted internal audits and supplier approval audits
- Monitor Trends for Customer Satisfaction, On-Time Delivery, and External Providers
- Document Control, Developed training grids to cross-train employees and maintain employee training records
- Reviewed and updated ISO-9000 and ISO/TS 16949 procedures, work instructions, inspection, and test instructions
- Develop and implement corrective action
- Conducted, documented, and reported weekly internal audits of Steel Mill processes
- Maintain registration of quality system through annual surveillance audits by registrar
- Analyzed inspection data from multiple inspection operations
- Coordinated development of Control Plans and Failure Mode and Effects Analysis (FMEA)
- Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
- Completed deviation forms and recorded findings of inspection process, collaborating with quality team members and department managers to implement procedural remedies.
- Maintained calibration while scheduling routine, preventive and reparative maintenance to maintain production workflows and achieve production output benchmarks.
- Educated employees on specific QA standards and confirmed maintenance of standards.
- Developed monthly, end-of-quarter and other statistical reports for leadership team and quality improvement programs.
- Collected and analyzed activity data and initiated, developed and recommended improvements to systems, processes and procedures to increase productivity .
Education
Certified State-Tested Nurse Assistant Surgical Technician- 2 years Ohio Health -
Butler Technology And Career Development Schools
Hamilton, OH1999
Diploma - General Studies CDL
Carlisle High School
Carlisle, OH06.1983
Skills
- Quality assurance requirements- ISO:20105, AS9100D, IATF 16949 2016, Nadcap, cGMP, OSHA 18001 Safety and 14000 Environmental Standards
- FDA Regulations
- FAA Regulations
- Lean Manufacturing
- Continuous Improvement
- Management -Quality Leadership
- Staff and Employee Quality development
- Blueprints / Drawings
- APQP- Smartsheet, Oracle & Global Shop
- AS9100 Lead Auditor
- Statistical Tools / Problem Solving
- Microsoft
- Attention to Detail
- Quality control tests
- Policy reinforcement
- Pre-implementation audits
- Systems Analysis
- Controls recommendation
- Risk Management
- Internal Quality Assurance Management
- Quality assurance expertise
- Defined testing and acceptance strategies and determined quality assurance benchmarks
- Quality assurance reviews
Certification
AQA AS9100 Rev D & ISO 9001;2015 Lead Auditor
November 2019 to November 2023
CDL - Professional Driver
July 2010 to Present
OSHA 20 Hour Safety Training Certificate
December 2011 to Present
Timeline
Quality Assurance Manager – Certified Lead Auditor
Renegade Materials Corp
05.2020 - 01.2022
Quality & Safety Manager – Certified Lead Auditor
MENDENHALL TECHNICAL SERVICES, INC
04.2019 - 01.2020
Corporate ISO Manager
LSI Industries
10.2018 - 04.2019
Quality Manager
Exact Metrology Inc.
09.2017 - 10.2018
Quality Manager
Newman Sanitary Gasket
02.2015 - 09.2017
Quality Assurance Specialist
Phoenix Technologies/ AK Steel
12.2011 - 01.2015
Certified State-Tested Nurse Assistant Surgical Technician- 2 years Ohio Health -
Butler Technology And Career Development Schools
Diploma - General Studies CDL
Carlisle High School