Heather Broeker
Urbana,IL
Summary
Quality management professional with robust experience in driving process improvements and ensuring compliance with industry standards. Skilled in Root Cause Analysis, CAPA, Deviations, Non-conformance, Auditing, and Quality Control Methodologies. Strong focus on team collaboration and achieving results, adaptable to changing needs. Known for reliability, problem-solving abilities, and effective communication.
Overview
14
14
years of professional experience
Work History
Remote Senior Manager, Corporate Quality Systems
Combe Incorporated
01.2025 - Current
- Lead and improve corporate-wide quality systems to ensure compliance with ISO 13485, FDA, and MDR standards.
- Drive the development and deployment of a new enterprise-wide ERP system, enhancing efficiency by 25%.
- Oversee supplier quality management, auditing global suppliers, and reducing supplier non-conformances by 20%.
- Act as Deputy Management Representative for ISO 13485:2016, supporting executive compliance strategy.
- Facilitate internal audits and manufacturing site inspections, ensuring ongoing regulatory adherence.
- Develop and implement validation plans for new ERP system, ensuring compliance and operational success.
- Drive corporate-wide training initiatives on quality systems, compliance, and regulatory expectations.
- Lead CAPA & deviation investigations, cutting resolution time by 40% through improved processes.
Remote Quality Systems Manager
Combe Incorporated
07.2021 - 12.2024
- Spearheaded harmonization of quality systems across 3 company locations and reduced redundancy in processes by 50%.
- Managed 500 supplier profile, audits & risk-based supplier evaluations, along with enhancing supplier quality for regulatory compliance.
- Established audit programs for Corporate and 2 manufacturing sites to ensure readiness for ISO 13485:2016 and FDA Drug audits.
- Led onboarding and training of all new employees, ensuring seamless integration into the quality framework.
- Developed and maintained Distribution Center Quality Systems, develop and create quality agreements, and build a risk-based audit schedule.
Analytical Quality Control Manager
Combe Laboratories
07.2017 - 07.2021
- Manage Analytical laboratory, along with personnel, to oversee daily functions and release of product. Manage metrology system for plant, along with performing any CAPA required.
- Manage laboratory compliance with applicable standards and regulations, along with performing audits.
- Improved processes in various areas including sampling process, documents, and laboratory by 75% efficiency.
- Responsible for performing CAPA as well as deviations required for quality.
- Responsible or overseeing, as well as writing, Out of Spec Investigations.
- Maintain and oversee incoming laboratory for packaging components.
- Responsible for performing review and submit time approvals for employees.
- Perform CAPA and deviations when required.
Analytical Lab Supervisor / Chemist
Combe Laboratories
10.2016 - 07.2017
- Perform testing and release of over 150 different raw materials for production, as well as product for release. Review documentation and training procedures and help to simply processes within the Analytical laboratory.
- Perform routine testing and release of raw materials and batches for production.
- Review specifications and request updates to be made when new materials are qualified.
- Develop and implement new laboratory investigation reports and forms.
- Streamline processes for testing of materials, as well as documentation required by 60%.
- Developed strong working relationships with other departments, ensuring seamless integration of laboratory services within the larger organizational ecosystem.
Analytical Lab Manager
KIK Custom Products
03.2011 - 09.2016
- Fostered a positive working environment by promoting open communication among team members and addressing any conflicts promptly.
- Actively participated in professional conferences and workshops, sharing laboratory best practices and fostering a culture of continuous improvement.
- Improved laboratory efficiency by streamlining workflows and implementing process improvements.
- Interviewed, hired and trained lab technicians to perform experiments and analyze results.
Education
M.S. - Management
Southern New Hampshire University
Manchester, NH11.2024
B.S. - Science
Illinois State University
Normal, IL12.2010
Skills
- Quality System Owner
- ERP Implementation
- Process Auditing and Improvement
- Risk Management
- Document Management including Report Writing
- Cross Functional Collaboration and Communication
- Supplier Management
- Troubleshooting and Problem Resolution
Timeline
Remote Senior Manager, Corporate Quality Systems
Combe Incorporated
01.2025 - Current
Remote Quality Systems Manager
Combe Incorporated
07.2021 - 12.2024
Analytical Quality Control Manager
Combe Laboratories
07.2017 - 07.2021
Analytical Lab Supervisor / Chemist
Combe Laboratories
10.2016 - 07.2017
Analytical Lab Manager
KIK Custom Products
03.2011 - 09.2016
M.S. - Management
Southern New Hampshire University
B.S. - Science
Illinois State University
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