Open To Work
Heather Felton
Senior Quality Assurance Specialist, ASQ-CQA and CSQE certified
Middleton,Wisconsin
Summary
Senior QA Specialist with a strong focus on GxP regulatory compliance and ISO standards. Demonstrated success in leading QA processes and fostering interdepartmental collaboration to improve quality management systems. Extensive experience in software validation and vendor audit management. Exceptional problem-solving and communication skills enhance project navigation and team collaboration.
Overview
18
18
years of professional experience
2
2
Certifications from American Society for Quality
Certification
- ASQ Certified Quality Auditor (CQA), Dec2012-Present
- ASQ Certified Software Quality Engineer (CSQE), Aug2017-Present
Education
Bachelor of Science - Biology
University of Wisconsin-Madison
WI, USA 08.2002 - 05.2007
Skills
- GxP regulatory compliance
- ISO standards implementation
- Attention to detail
- Training design
- Problem solving
- Effective communication
- Critical thinking
- Version control systems
- ISO 13485 and 14971 compliance
- ICH E6 guidelines adherence
- 21 CFR Parts 11 and EU Annex 11 compliance
- 21 CFR Parts 50, 54, and 56 regulations
- 21 CFR Part 58 requirements adherence
- 21 CFR Parts 211, 803, and 820 regulations
- Software as a Medical Device (SaMD) validation
- Corrective and preventive actions (CAPA)
- Quality management systems (QMS) implementation
- Risk management strategies
- Process improvement methodologies
- Software validation processes
- Data privacy compliance including ISO 27001, HIPAA, GDPR
- Cross-department and team collaboration
- Software development lifecycle
- Test plan creation
- Configuration management
- Analytical thinking
- Documentation and reporting
- Decision-making
- Establishing and enforcing policy
- Technical writing including SOPs
Timeline
Senior Quality Assurance Specialist
MERIT CRO
04.2019 - 08.2025
Quality Assurance Manager
EyeKor, Inc. (Now MERIT CRO)
09.2014 - 04.2019
Quality Assurance Auditor
PPD, Inc.
07.2008 - 04.2014
Nutrition Application and Regulatory Consultant
Kraft Foods Corporation
11.2007 - 06.2008
Field Research Assistant
University of Wisconsin – Madison
05.2007 - 10.2007
Bachelor of Science - Biology
University of Wisconsin-Madison
08.2002 - 05.2007
Sales Associate
Gander Mountain
07.2001 - 10.2006
Girl Scout Camp Counsler
Girl Scouts of Kansas Heartland
06.1997 - 08.2000
Work History
Senior Quality Assurance Specialist
MERIT CRO
Madison, Wisconsin
04.2019 - 08.2025
- Lead QA related software validation processes and activities for customized software and COTS.
- Manage and conduct assessments, qualifications, and audits of vendors and contractors.
- Develop and maintain electronic systems for configuration, learning, and quality management.
- Collaborate with IT to implement GDPR and HIPAA-compliant policies using ISO 27001 framework.
- Collaborate across departments to develop and maintain the QMS per ISO 13485 and 21 CFR Part 820 frameworks.
- Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
- Educated employees on specific QA standards and confirmed maintenance of standards.
- Skilled at working independently and collaboratively in a team environment.
Quality Assurance Manager
EyeKor, Inc. (Now MERIT CRO)
Madison , Wisconsin
09.2014 - 04.2019
- Created and maintained quality management systems to align with industry standards per 21 CFR Part 820 and ISO 13485.
- Established and tracked quality department goals and objectives.
- Provided regulatory guidance for GLP, and GCP studies.
- Conducted software validation documentation reviews per GMP requirements.
- Managed internal audits, client audits, and regulatory inspections.
- Conducted process and system audits to identify areas of improvement and enforce compliance with industry standards.
- Collaborated with audit clients,regulatory authorities, and action owners to apply root cause analysis guidance and establish effective corrective action plans.
- Investigated customer complaints and performed corrective actions to resolve quality issues.
- Conducted risk assessments to identify and mitigate potential quality issues.
- Scheduled and chaired quality review meetings to review effectiveness of performance mitigating risk, improving throughput and achieving customer satisfaction.
Quality Assurance Auditor
PPD, Inc.
Middleton, Wisconsin
07.2008 - 04.2014
- Audited laboratory data and reports for compliance with SOPs.
- Conducted inspections of laboratory procedures.
- Performed routine and specialized audits ensuring regulatory compliance.
- Reviewed and approved method, software, and equipment validations.
- Trained and reviewed work of junior personnel on departmental responsibilities.
- Identified issues of non-compliance, aided in non-compliance documentation, including root cause analysis, and CAPA, and elevated reports to senior personnel.
Nutrition Application and Regulatory Consultant
Kraft Foods Corporation
Madison, Wisconsin
11.2007 - 06.2008
- Assisted with regulatory product compliance initiatives such as nutritional labeling.
- Designed and organized ingredient change experiments from start to finish by designing effective sampling plans and data analysis methodologies.
- Tested and labeled products for accurate nutritional data.
- Prepared and maintained document inventory for core dossier preparation.
- Reviewed food nutritional data to assess compliance with USDA and FDA labeling regulations.
- Prioritized project-related tasks to efficiently complete essential tasks.
Field Research Assistant
University of Wisconsin – Madison
Madison, Wisconsin
05.2007 - 10.2007
- Collected amd recorded field data for integrated pest management research.
- Created and implemented procedures to obtain required information and support research goals.
- Assisted agricultural and entomology scientists with in-depth data research in both lab and office environments.
- Reviewed and verified data before entering into database to enhance research quality and accuracy.
- Used strong analytical and problem-solving skills to develop effective solutions for challenging situations.
Sales Associate
Gander Mountain
Madison, Wisconsin
07.2001 - 10.2006
- Trained and supported new employees during new hire orientation.
- Solved customer challenges by offering relevant products and services.
- Helped customers locate products and checked store system for merchandise at other sites.
- Delivered energetic responses to customers in-store and by telephone, going above and beyond to serve needs.
- Maintained calm demeanor and professionally managed issues in busy, high-stress situations.
- Rotated stock and restocked shelves to maintain product availability and store appearance.
Girl Scout Camp Counsler
Girl Scouts of Kansas Heartland
Wichita, Kansas
06.1997 - 08.2000
- Worked with children of varying age, interest, skill, and developmental levels.
- Collaborated with other camp counselors to design fun and enriching learning activities for campers.
- Led groups of children safely through variety of camp activities.
- Provided clear instruction to activity and program participants to deliver fun and maintain safety.
- Monitored participation in recreational activities to provide assistance to participants.
- Supervised camper activities to address behavioral issues and promote fun, safety and inclusivity.
- Assisted in preparing recreational materials and supplies for each activity.
Work Preference
Work Type
Full TimePart TimeContract WorkLocation Preference
RemoteReferences
References available upon request.