Sally VanHorn
Burnsville
Summary
Dynamic individual with extensive experience in compliance and talent for navigating challenges. Brings strong problem-solving skills and proactive approach to new tasks. Known for adaptability, creativity, and results-oriented mindset. Committed to making meaningful contributions and advancing organizational goals.
Overview
21
21
years of professional experience
1
1
Certification
Work History
Senior Quality Systems Engineer
Resonetics
11.2022 - Current
- Champion a culture of continuous improvement, encouraging team members to identify opportunities for process optimization and cost reduction.
- Conduct root cause analysis to identify areas for improvement, leading to a reduction in product defects.
- Establish, document and maintain all Quality Assurance policies and procedures across all locations.
- Manage internal audit program and act as lead auditor for internal audits.
- Act as primary contact for customer and regulatory audits.
- Establish and maintain the policies necessary to ensure companywide compliance to ISO and government regulations.
- Take ownership of assigned production readiness activities to ensure that quality awareness is inherent in process development.
- Develop and assist with development of standard operating procedures, including solicitation of functional department input and participation in process development.
- Conduct weekly/monthly reporting of activities and key metrics.
- Customer liaison for quality system related issues. May assume project manager role for specific customer applications.
- Train employees on quality principles and procedures.
- Administer and improve quality management system, including its quality information systems.
- Assist with Managing complaints and corrective/preventive action processes
Validation Engineer
Lifecore Biomedical
01.2017 - 03.2020
- Validated software for compliance with industry standards, enhancing overall system integrity.
- Conducted root cause analysis on deviations during validation activities, enabling timely resolution of technical issues.
- Reduced operational risks associated with validated systems through periodic review assessments and targeted revalidations when necessary.
- Contributed to successful audits by providing detailed validation documentation and addressing any regulatory findings promptly.
- Managed multiple validation projects simultaneously while adhering to strict deadlines and budget constraints.
- Improved validation processes by developing and implementing risk-based strategies for software validation.
- Streamlined the revalidation process by identifying opportunities for consolidation or elimination where appropriate.
- Evaluated change control requests to assess potential impacts on validated systems, ensuring ongoing compliance with regulations.
- Collaborated with cross-functional teams for identification and resolution of validation issues.
- Developed validation master plans, process flow diagrams and standard operating procedures.
- Drove corrective actions to accomplish project closure and recurrence control.
- Led the audit back room for numerous customer and regulatory audits to assist with reaching company goal of 100% annual audit closure.
Systems Integration Scientist
Beckman Coulter
09.2003 - 03.2013
- Provided planning, quality control, data analysis, and laboratory testing support for the hardwareresearch and development, manufacturing, and quality departments.
- Participated in and lead systems (mechanical, electrical, software, and chemistry) design and development projects.
- Created project strategy, risk assessment, regulatory support, and test protocol documents, routed forapproval in electronic document system and released to appropriate parties.
- Built relationships with new and existing vendors to facilitate transfer of product.
- Provided audit support, assisted with regulatory submissions, participated in FDA audit, and assisted with 483 responses.
Education
Bachelor of Arts - Applied Engineering
Bemidji State University
Bemidji, MN07-2022
Associate of Arts - General Studies
Normandale Community College
Bloomington, MN03-1995
Skills
- Quality training
- Corrective and preventive actions
- CAPA management
- Quality management systems
- Process validation
- Validation techniques
- Customer complaint handling
- Process improvement
- Software development lifecycle
- Compliance
- Lean manufacturing techniques
- Critical thinking
- Organizational skills
- Team collaboration
- Active listening
- Effective communication
- Adaptability and flexibility
Languages
English
Native or Bilingual
Affiliations
- American Society for Quality
- Association of Technology, Management and Applied Engineering
- Veterans of Foreign Wars
Certification
- ASQ Certified Quality Engineer since December 2016
- ASQ Certified Manager of Quality/Organizational Excellence since 2020
- Six Sigma Yellow Belt
- ISO 13485:2016 Lead Auditor
- ISO 13485:2016 Internal Auditor
- ISO 19011 Lead Auditor
Timeline
Senior Quality Systems Engineer
Resonetics
11.2022 - Current
Validation Engineer
Lifecore Biomedical
01.2017 - 03.2020
Systems Integration Scientist
Beckman Coulter
09.2003 - 03.2013
- ASQ Certified Quality Engineer since December 2016
- ASQ Certified Manager of Quality/Organizational Excellence since 2020
- Six Sigma Yellow Belt
- ISO 13485:2016 Lead Auditor
- ISO 13485:2016 Internal Auditor
- ISO 19011 Lead Auditor
Bachelor of Arts - Applied Engineering
Bemidji State University
Associate of Arts - General Studies
Normandale Community College
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