GINA BUCKMAN
Louisville,CO
Summary
Dynamic Quality Manager with extensive experience in managing and implementing ISO 13485 and AS9100 standards. Proven track record in leading cross-functional teams to drive continuous improvement and enhance supplier quality. Skilled in CAPA management and effective communication, ensuring compliance and operational excellence in quality management systems.
Overview
1
1
Certification
Work History
Quality Manager
Spectra Logic
Boulder, CO
2023 - 2025
- Oversaw Quality Management System, ensuring compliance with standards and customer requirements to maintain product quality.
- Directed document control, training records, CAPA/NCR processes, and internal audit planning to streamline quality operations.
- Partner with leadership to define quality metrics, perform trend analysis, and present performance data to management.
- Led cross-functional problem-solving efforts to resolve systemic issues and advance continuous improvement initiatives.
Quality Engineer II
Blue Canyon Technologies
Lafayette, CO
2022 - 2023
- Temporary replacement position
- Managed quality assurance processes for mechanical parts and hardware components, ensured adherence to established standards.
- Managed NCRs, CAPAs, SCARs, and deviations, ensuring timely closure and implementation of effective corrective actions.
- Author, review, and approve quality documentation including work instructions, deviations, and CAPA documentation.
- Conducted supplier quality audits and assessments, leading discussions with suppliers on part quality and nonconformance resolutions.
- Support AS9100 certification preparation, focusing on nonconforming product, supplier quality, and documentation readiness.
IVD Quality Specialist
Invitae
Boulder, CO
2021 - 2022
- Managed CAPAs and NCRs for IVD products; ensured robust root cause analysis and effectiveness verification.
- Reviewed IVD Job Traveler packets, lab results, and test methods for accuracy and completeness prior to product release.
- Performed product release and Device History Record (DHR) reviews and approvals.
- Managed temperature logger monitoring and ensured compliance with temperature-sensitive shipping requirements.
- Collaborated as internal and external audit team member; addressed ISO/AS audit findings and coordinated corrective actions with stakeholders to enhance compliance.
- Developed training program to ensure employees met training requirements and maintained accurate documentation.
- Authored and maintained procedures and work instructions; assisted with document control administration.
- Termination of position resulting from company-wide layoffs
Quality Manager
Action Industries
Arvada, CO
2020 - 2021
- Temporary position for ISO Audit preparation -prepared the company for ISO 13485:2016 and AS9100D recertification and served as lead auditee.
- Reviewed Quality Management System, ensuring compliance with ISO and AS standards.
- Planned and conducted system-wide internal audits; reported results, tracked actions, and verified implementation.
- Conducted Management Review meetings, maintaining action lists and ensuring implementation.
- Managed CAPAs, NCRs, and training records, facilitating contract review for new jobs.
- Oversaw calibration and metrology requirements; maintained calibration records and compliance.
- Developed and maintained training programs, including Non-Disclosure Agreements, Safety, ITAR, and Cybersecurity.
Quality Assurance Coordinator
Molecular Products
Louisville, CO
2018 - 2020
- Administered CAPA program including root cause investigations, action plans, implementation, and effectiveness reviews.
- Managed nonconforming material and MRB functions, reporting findings and trending performance metrics to drive quality improvements.
- Managed deviations and document control activities, overseeing creation, revision, and approval of quality documents to ensure compliance.
- Planned and administered quality audits; prepared for and participated as auditee during external audits.
- Managed supplier scoring, performance tracking, audits, SCARs, and specification documents.
- Supported risk management through FMEAs and risk assessments, analyzing performance data to identify potential quality issues.
- Acted as ITAR and EAR administrator; conducted audits of export control processes and program adherence.
Associate / Office Manager, Tax Resolution
Front Range Tax Resolution
2012 - 2015
- Provided tax debt consultation and negotiated resolutions with the IRS and all 50 state taxing authorities.
- Analyzed financial statements for individuals and businesses; drafted Offers in Compromise and payment plan proposals to facilitate tax resolution.
- Managed case files and deadlines; coordinated follow-up with clients and Revenue Officers to ensure timely communication and resolution.
- Prepared IRS forms (433-A, 433-B), appeals requests, and tax lien discharge/subordination proposals with supporting financial documentation for client cases.
- Created and analyzed profit and loss statements and supported contract negotiation and sales.
- Utilized Excel, Word, PowerPoint, Access, email, and calendar at an expert level.
Education
Bachelor's Degree - Anthropology, Evolutionary Biology, Leeds Business
University of Colorado
Boulder, CO01.2020
Undergraduate coursework - Biology, Anthropology
Metropolitan State University of Denver
Denver, CO01.2016
Skills
- Quality Management
- QMS Implementation
- ISO 13485
- ISO 9001
- AS9100
- CGMP
- GLP
- Quality Assurance
- Internal Audits
- External Audits
- Supplier Quality
- Supplier Quality Audits
- SCARs
- CAPA
- CAPA Management
- NCR
- MRB
- Risk Management
- FMEA
- Deviations
- Document Control
- Quality Audits
- Continuous Improvement
- Process Improvement
- Validation
- Validation Management
- Training Systems
- Training Development
- Laboratory Experience
- Lean Manufacturing
- 5S
- Statistical Analysis
- Minitab
- ERP Systems
- GAGEtrak
- Calibration
- Metrology
- Quality Inspection
- GD&T
- Calipers
- Micrometers
- Measurement Systems
- Sampling Plans
- SOP Review
- Budget Preparation
- Performance Metrics
- Data Analysis
- Cybersecurity Awareness
- Project Management
- Supervising
- Leadership
- Cross-Functional Team Lead
- Cross-Functional Collaboration
- Effective Communication
- Group Training
- Presentation
- Public Speaking
- Financial Writing
- Business Proposal Writing
- Customer Service
- Supply Chain Coordination
- Operational Improvements
- Internal Auditing
- External Audit Support
- Issue Resolution
- Typing
- 10-Key Data Entry
- Certified quality auditor
- Budget preparation
- Sampling plans
- Validation management
- Operational improvements
- SOP review
- Failure mode and effects analysis
- Issue resolution
Certification
- ISO 13485 Internal Auditor Training
- ISO 9001 Lead Auditor Training
- IPC-610 Certification
- First Aid, CPR, AED Certified
Personal Information
Title: Quality Systems & Compliance Specialist
Languages
- French, Intermediate
- Spanish, Basic
Timeline
Quality Manager
Spectra Logic
2023 - 2025
Quality Engineer II
Blue Canyon Technologies
2022 - 2023
IVD Quality Specialist
Invitae
2021 - 2022
Quality Manager
Action Industries
2020 - 2021
Quality Assurance Coordinator
Molecular Products
2018 - 2020
Associate / Office Manager, Tax Resolution
Front Range Tax Resolution
2012 - 2015
Bachelor's Degree - Anthropology, Evolutionary Biology, Leeds Business
University of Colorado
Undergraduate coursework - Biology, Anthropology
Metropolitan State University of Denver