Linda Miller
Stephenville,TX
Summary
Professional auditor prepared to deliver results through rigorous analysis and comprehensive audits. Skilled in risk assessment, internal controls, and regulatory compliance with focus on team collaboration and adaptability to changing needs. Known for reliability, thorough communication, and strategic problem-solving. Passionate about driving organizational improvements and ensuring quality integrity.
Overview
21
21
years of professional experience
1
1
Certification
Work History
Corporate Quality Principal Auditor
Zimmer Biomet
02.2022 - Current
- Developed strong relationships with key stakeholders, fostering a collaborative approach to audits and risk management.
- Enhanced audit efficiency by implementing risk-based audit methodologies and data analytics tools.
- Ensured timely completion of audits by effectively managing resources and prioritizing tasks based on risk assessments.
Corporate Quality Audit Specialist
BD Corporate
11.2020 - 01.2022
- Maintained accurate records of audit findings, allowing for effective tracking of progress toward quality goals and identification of recurring issues.
- Performed review and analysis of all site post audit submissions and support with CAPA
Manager Quality Compliance
BD MDS
02.2019 - 11.2020
- As part of quality management team, performed gap analysis and remediation of quality systems
- Performed internal audits and hosted both customer and regulatory audits including FDA and NMPA
- Managed and motivated employees to be productive and engaged in work.
Associate Manager Quality - Compliance
BD PAS
09.2016 - 02.2019
- Facilitated the Training department, CAPA, Supplier Management, Audits, Documentation, Microbiology Lab
- Collaborated closely with senior management on strategic planning efforts, aligning departmental goals with overarching company objectives.
- Successfully managed multiple high-priority tasks simultaneously while maintaining strict deadlines ensuring optimal resource allocation.
Quality System Specialist II - Compliance
BD PAS
11.2014 - 09.2016
- Managed the Corrective and Preventative Action Program, Internal Audits, and Supplier Management & Audits
- Identified opportunities for process improvements by analyzing user feedback and monitoring key performance metrics closely.
- Conducted regular system audits, ensuring compliance with industry regulations and company policies.
Quality System Specialist II – Complaint Management
BD PAS
05.2012 - 11.2014
- Identified opportunities for process improvements by analyzing user feedback and monitoring key performance metrics closely.
- Troubleshot critical issues swiftly, maintaining a consistently high level of system performance and reliability.
Lead Analyst/Analyst Chemistry Lab
BD PAS
06.2003 - 05.2012
- 5 years as an Analyst and promoted to Lead Analyst in August 2008
- Improved overall team efficiency by streamlining processes and implementing new analytical tools.
Education
Master of Science - Quality Systems
Florida Institute of Technology
Melbourne, FL12.2017
Skills
- FDA 21 CFR 820
- ISO 13485
- MDSAP / EU MDR
- Audit process management
- Quality Management Systems
- Strong Work Ethic
- Teamwork and Collaboration
- Effective Communication
- Organizational Skills
Certification
- Certified Quality Auditor (CQA) - American Society for Quality
Timeline
Corporate Quality Principal Auditor
Zimmer Biomet
02.2022 - Current
Corporate Quality Audit Specialist
BD Corporate
11.2020 - 01.2022
Manager Quality Compliance
BD MDS
02.2019 - 11.2020
Associate Manager Quality - Compliance
BD PAS
09.2016 - 02.2019
Quality System Specialist II - Compliance
BD PAS
11.2014 - 09.2016
Quality System Specialist II – Complaint Management
BD PAS
05.2012 - 11.2014
Lead Analyst/Analyst Chemistry Lab
BD PAS
06.2003 - 05.2012
- Certified Quality Auditor (CQA) - American Society for Quality
Master of Science - Quality Systems
Florida Institute of Technology
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