SARAH MISHOU
Sugar Land,TX
Summary
Multi-talented Senior Manager well-versed and highly effective at developing, executing and directing key improvements to enable business enhancements and growth. Visionary leader with solid success leading business operations toward growth. Accomplished, metrics-driven Leader and Lean Six Sigma Black Belt with a proven record of driving operational excellence, compliance, and talent development across highly regulated manufacturing and medical environments. Expert at bridging the gap between Quality Assurance (QA) regulations and workforce capability, successfully managing teams of up to 107 employees and delivering over $500,000 in continuous improvement cost savings. Demonstrated success implementing scalable electronic Learning Management Systems (LMS), authoring robust cGMP/FDA-compliant training frameworks, and leading cross-functional teams through successful Notified Body and supplier audits. A strategic change agent skilled at leveraging instructional design, adult learning principles, and organizational development to maximize employee engagement and align human capital with overarching business objectives.
Overview
1
1
Certification
15
15
years of professional experience
Work History
Senior Manager, Training Design
PURITAN MEDICAL PRODUCTS COMPANY LLC
Guilford, Maine
04.2026 - 05.2026
- Spearheaded the strategic creation and implementation of scalable, compliant, company-wide learning initiatives across all corporate and remote departments.
- Directed end-to-end curriculum development and instructional design frameworks, ensuring full alignment with strict organizational goals and regulatory standards.
- Supervised and mentored high-performing team of training & development professionals, aligning content delivery with measurable learner outcomes.
- Maintained 100% engagement and compliance metrics across organizational training, adapting content for complex cross-functional teams.
- Secured and managed workforce development grants through proactive research, funding expansion of organizational training programs.
Senior Manager, Quality Assurance
PURITAN MEDICAL PRODUCTS COMPANY LLC
Guilford, Maine
10.2022 - 04.2026
- Led migration and implementation of electronic Learning Management System (LMS), optimizing compliance and development training delivery.
- Directed training branch within Quality department, enhancing efficiency and relevance of training programs.
- Acted as Subject Matter Expert (SME) for electronic quality systems, documentation management, and data integrity using MasterControl.
- Orchestrated audit preparation activities for Notified Body, supplier, and customer audits, ensuring robust regulatory compliance.
- Revamped Internal Auditing program, standardizing audit schedules, developing audit methods, and mentoring team members for BSI Lead Auditor Certification.
- Partnered with cross-functional leadership to redesign and execute a regulatory-compliant Management Review process that successfully reduced operational compliance gaps.
Employee and Worker Outreach Specialist (Short-Term Grant Contract)
TXRX LABS
Houston, TX
01.2022 - 07.2022
- Led recruitment, onboarding, and compensation processes for high-volume job training non-profit program, enhancing candidate experience.
- Accelerated trainee placement rates within manufacturing companies through targeted business development and strategic partner collaboration.
- Coordinated needs assessments with corporate partners, managed candidate interviews, and facilitated placement of technical personnel.
- Engineered an accelerated onboarding workflow that successfully processed and prepared new trainee cohorts every two weeks.
- Created advanced Excel reporting models for daily, weekly, and monthly performance tracking, improving stakeholder insights.
Performance and Organizational Specialist / Compliance & QA Admin
ALCON MANUFACTURING
Houston, TX
05.2016 - 04.2021
- Directed facility-wide compliance, skill, and regulatory training across all operational departments.
- Designed and deployed cGMP training materials in strict accordance with FDA Quality Systems Regulations (21 CFR Part 820) and ISO 13485 standards.
- Pioneered the swift transition to virtual training programs during COVID-19, eliminating gaps in plant-wide onboarding and orientation.
- Established innovative training structures, including "Train-the-Trainer" certifications and Qualified Trainer Programs based on adult learning principles, enhancing organizational training effectiveness.
- Managed SOP revision and system records within Global Plateau System (GPS) and Veeva Vault LMS to mitigate compliance risks during major agile system migration.
- Authored, reviewed, and consolidated manufacturing SOPs, successfully conducting gap analyses to reduce procedural redundancies.
- Drove over $500,000 in cost savings by developing and implementing Lean continuous improvement projects (including OJT Task breakdowns and TWI).
- Mentored Green Belt and Yellow Belt candidates, serving as a Lean Six Sigma Black Belt instructor to scale continuous improvement capabilities.
- Partnered with senior executives as a corporate Diversity & Inclusion Ambassador to execute cultural assessments, enhancing employee engagement.
Production Line Supervisor
ALCON MANUFACTURING
Houston, TX
08.2011 - 05.2016
- Drove all production and assembly activities across high-volume manufacturing lines while strictly enforcing GMP laws and plant safety standards.
- Managed performance for 107 direct labor employees, minimizing turnover and optimizing labor hours.
- Balanced production lines and optimized operational workflows using Lean tools (Charter, A3, DMAIC, SIPOC, VSM) to decrease inventory overhead and eliminate waste.
- Redesigned production On-the-Job Training (OJT) process, reducing trainee time-to-productivity.
- Managed critical Human Resources workflows, processing departmental payroll through Etime, HRCore, and Workday while handling conflict resolution.
Education
Master of Science - Human Relations and Business (HR Management)
Amberton University
Garland, TXBachelor of Arts - Communication Studies
University of Houston-Downtown
Houston, TXAssociate of Arts - General Studies
Houston Community College
Houston, TXSkills
- L&D / Instructional Design: LMS expertise, Adult Learning Principles, Curriculum Design, Curriculum mapping, Training programs, Training Facilitation, Train-the-Trainer, Needs Assessment, On the Job Training (OJT), LMS administration
- Quality & Regulatory Compliance: QMS proficiency, cGMP, FDA compliance, ISO 13485, Audit management, Audit preparation, SOP development, Project management
- Operations & Leadership: Lean Six Sigma (Black Belt), Team coordination, Operations management, Performance oversight, Succession strategy, Conflict Resolution, Employee development strategies, Team leadership, strategic planning, stakeholder communication, Analytical thinking, Report management
- Technical Systems: MasterControl, Veeva Vault, GPS expertise, Workday, HRCore, Etime, Microsoft Excel (Advanced Reporting)
Certification
Lean Six Sigma Black Belt Training | BSI Certified Lead Auditor | TWI Certified
Timeline
Senior Manager, Training Design
PURITAN MEDICAL PRODUCTS COMPANY LLC
04.2026 - 05.2026
Senior Manager, Quality Assurance
PURITAN MEDICAL PRODUCTS COMPANY LLC
10.2022 - 04.2026
Employee and Worker Outreach Specialist (Short-Term Grant Contract)
TXRX LABS
01.2022 - 07.2022
Performance and Organizational Specialist / Compliance & QA Admin
ALCON MANUFACTURING
05.2016 - 04.2021
Production Line Supervisor
ALCON MANUFACTURING
08.2011 - 05.2016
Master of Science - Human Relations and Business (HR Management)
Amberton University
Bachelor of Arts - Communication Studies
University of Houston-Downtown
Associate of Arts - General Studies
Houston Community College