Sarah Battles
Lake Elmo,MN
Summary
Results-driven Quality Systems Manager with extensive experience at RMS Company, adept at ensuring compliance with FDA and ISO 13485 regulations. Proven track record in leading audits, enhancing product quality, and training teams. Skilled in project management and effective communication, successfully reducing defects and improving operational efficiency in fast-paced environments.
Overview
20
20
years of professional experience
1
1
Certification
Work History
Quality Systems Manager
RMS Company
Lake Elmo, MN
08.2011 - Current
- Developed and maintained a quality management system that is compliant with ISO and FDA regulations for medical manufacturing.
- Led and managed regulatory and customer audits, implementing corrective actions as necessary.
- Ensured compliance with ISO 13485 and FDA 21 CFR 820, communicating policy updates to staff.
- 510k and MRD submissions.
- Created monthly inspection and improvement reports.
- Directed quality control teams to investigate processes and identify deficiencies.
- Supervised and mentored quality control personnel.
- Developed and implemented quality assurance programs, verifying their effectiveness.
- Evaluated and improved eIP, and SPC systems.
- Oversaw daily operations and technical support for a department of 200 employees.
- Trained employees in enhanced quality procedures to reduce errors.
- Collaborated with Engineering and Manufacturing to resolve systemic issues, reducing error and rework rates.
- Trained staff in sampling techniques, raw material testing, and product inspection strategies.
- Conducted internal audits to assess effectiveness of quality processes.
- Implemented corrective actions to address non-conformance in operations.
- Communicated quality control information to relevant organizational departments, outside vendors and contractors.
Quality Supervisor
Tescom
Elk River, Minnesota
06.2009 - 07.2011
- Supervised quality control processes for Hydrogen station control panel & hydrogen dispenser
- Facilitated cross-functional meetings to discuss quality initiatives.
- Trained team members on compliance with regulatory standards.
- Collaborated with engineering teams to resolve quality issues.
- Implemented process improvements to enhance efficiency and accuracy.
- Documented inspection results, maintained records, and reported on data trends.
- Enforced adherence to industry standards by monitoring employee performance during inspections.
- Conducted training sessions for employees on quality assurance procedures and methods.
Quality Control Lab Technician
Neurovasx, Inc.
Maple Grove, Minnesota
03.2008 - 05.2009
- Conducted quality tests on raw materials and finished products.
- Maintained laboratory equipment and ensured proper calibration.
- Documented test results and prepared reports for review.
- Collaborated with team members to resolve quality issues.
Final Quality Inspector
Boston Scientific
Maple Grove, Minnesota
01.2006 - 02.2008
- Worked in a fast-paced environment manufacturing implantable drug-eluting stents.
- Developed and implemented best practices to enhance efficiency and reduce defects.
- Streamlined QA processes in collaboration with development teams, adapting to changing product demands.
Education
Executive Education - Leadership Program
University of Minnesota, Carlson School of Management
Minneapolis, MN05.2024
General studies
Anoka Ramsey Community College
01.2006
Diploma -
Elk River High School
Elk River, MN01.2004
Skills
- Quality auditor
- Staff training
- Logistics
- scheduling
- Dedication to product quality
- FDA and ISO 13485 regulations
- Project management
- Audit management
- Regulatory affairs
- Team leadership
- Effective communication
Certification
- ISO 13485 / FDA 21 CFR 820 Lead Auditor – Exemplar Global
- Basic statistics – Cretex University
- Lean Leader PLX – Anoka Ramsey University
- Excel Advanced - Anoka Ramsey University
Timeline
Quality Systems Manager
RMS Company
08.2011 - Current
Quality Supervisor
Tescom
06.2009 - 07.2011
Quality Control Lab Technician
Neurovasx, Inc.
03.2008 - 05.2009
Final Quality Inspector
Boston Scientific
01.2006 - 02.2008
Executive Education - Leadership Program
University of Minnesota, Carlson School of Management
General studies
Anoka Ramsey Community College
Diploma -
Elk River High School