Melissa Tillinghast
Milton,DE
Summary
Dedicated and results-driven Quality Leader with over 15 years of experience in quality processes, change, document, and record control management. Proven expertise in strategic quality processes, compliance management, and team leadership. Seeking a challenging opportunity to leverage skills and experience in driving process improvements and fostering a culture of excellence. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Quality Leader
W.L. Gore & Associates, Inc.
08.2021 - Current
- Quality Leader, overseeing divisional quality processes and strategic direction.
- Serve as Subject Matter Expert during audits, focusing on Change Control, Document Control, and Record Control processes.
- Allocate daily tasks within the team to meet manufacturing objectives and deadlines, optimizing productivity and process adherence.
- Mentor and develop team members, fostering a culture of excellence and consistently achieving top rankings in contribution assessments.
- Monitor, analyze, and report divisional metrics to identify risks and opportunities, translating results into actionable quality objectives and improvements.
- Provide guidance to Associates, ensuring consistency in quality process execution and alignment with global standards.
- Balance compliance with practicality, enhancing user experience while promoting process maturity and employing error-proofing techniques to reduce errors.
- Lead divisional improvement initiatives, aligning them with business priorities and global strategies.
- Author globally aligned procedures to maintain standards and improve practices related to divisional procedures/documentation.
- Updated quality control standards, methods, and procedures to meet compliance requirements.
- Developed and maintained a comprehensive quality management system, ensuring adherence to regulatory guidelines and best practices.
- Managed and archived quality documentation and participated in internal and external quality audits.
- Mentored and encouraged employees to strive for excellence while fostering professional growth.
- Improved quality processes for increased efficiency and effectiveness.
- Led root cause analysis efforts for significant quality incidents, driving timely resolution and implementing preventative measures.
- Determined quality department standards, practices, and procedures.
Change Analyst/Document Control Administrator
W.L. Gore & Associates, Inc.
05.2008 - 08.2021
- Process Engineering Change Requests (ECRs) through the Quality System, ensuring precision and adherence to Management of Change standards.
- Safeguarded the accuracy and integrity of the Quality database and maintained comprehensive metrics.
- Developed and disseminated training materials, conducting targeted training sessions as needed.
- Initiated and led document control improvement projects to enhance system efficiency and reliability.
- Supported audits and inspections pertinent to Management of Change and document control, ensuring compliance and system integrity.
- Executed and maintained control over approved documents, ensuring continuous integrity of the Released Documents, Document Control, and Specification Control databases.
- Facilitated calibration activities by innovatively managing the creation, revision, and archival of Calibration documents (including Equipment Records, History Records, and Procedures).
- Partnered with the Quality Assurance team to devise and implement solutions for unique system usage challenges and scenarios.
Education
High School Diploma -
Bohemia Manor High School
Chesapeake City, MD06.1992
No Degree - Office Technology
Cecil County School of Technology
North EastSkills
- Quality Management Systems
- Document Control
- ISO standards knowledge
- Customer Service
- Operational Improvements
- Critical Thinking
- Corrective and Preventive Action
- Process Documentation
- Quality Risk Assessment
- Regulatory Compliance
- Quality Documentation
- Operational Excellence
- Employee Training
- Quality system audits
- Continuous Improvement
- Attention to Detail
Certification
- Team Leader Development Program
- Diversity, Equity, and Inclusion for Leaders
- Delivering Authentic Feedback
- Preventing Sexual Harassment in the Workplace
- Member of the Internal Audit Team
Timeline
Quality Leader
W.L. Gore & Associates, Inc.
08.2021 - Current
Change Analyst/Document Control Administrator
W.L. Gore & Associates, Inc.
05.2008 - 08.2021
High School Diploma -
Bohemia Manor High School
No Degree - Office Technology
Cecil County School of Technology