Manager, Failure Analysis and Quality Investigations

• Sep 2023 - Present

Quality Compliance Supervisor

• Jul 2022 - Sep 2023

- Drove cross-functional efforts to complete the annual Periodic Safety Update Report. Over the course of many months, I met with key members of Quality, Regulatory, and Data Analytics, and representatives from different departments to aggregate the data necessary and ensure the content of this report was clear, accurate, and met the intent of the regulations.- Through my operational planning efforts and arrangement of resources, the department hit KPIs during my tenure as the sole leader within PMQ (up to VP).- Implemented training tools, productivity metrics, and quality checklists to prioritize accountability, and professional growth for my team members, and create redundancies for core complaint-handling processes. Show less

Quality Compliance Lead

• Jan 2021 - Jul 2022

Process owner for reporting adverse events to worldwide regulatory agencies. Accomplishments:- Facilitated the team to consistently meet KPIs through data driven operational planning and increased accountability.- Automated click-heavy workflows across the entire complaint life cycle.

QA Compliance Specialist

• Jan 2019 - Jan 2021

Became intimately familiar with post market quality assurance activities.Accomplishments:- Created a monthly tracking tool to help the team meet quality objectives.

Technical Support Specialist

• Feb 2017 - Dec 2018

Learned the product suite at a detailed level in order to provide technical product support for patients, field representatives and medical professionals.Accomplishments:- Consistently top performing in team productivity metrics.- Identified an opportunity to improve quality, efficiency and accuracy for an existing printing process and took the project from start to finish, saving $250,000 annually.

Tech Support Engineer

• May 2012 - Jun 2016

Epic is the industry leader in Electronic Medical Records (EMR) systems and has been expanding their business internationally. I trained for 3 months at Epic’s headquarters near Madison, Wisconsin, learned the entire product suite at a high level and became intimately knowledgeable with the Dutch billing application. Accomplishments/responsibilities: - Maintained highest customer satisfaction ratings through managing relationships, delivering tech support and overseeing new deployments. - Assured product exceeded customer needs by delivering solutions through software development, debugging and workflow optimization. - Organized and facilitated all Dutch customers to successfully work together to implement regulatory changes in each of the last three years. - Ensured product compliance with regulations and lobbied to minimize development impact, by representing Epic at Dutch regulatory bodies and being involved in the decision-making processes for new regulations. Show less

Master student

• Sep 2010 - Sep 2011

Master graduation project at Roessingh Research & Development: Integrating chronic obstructive pulmonary disease exercise coaching into a body parameter controlled game. - Designing a serious game - Designing user requirements - Patient testing Master graduation project at Roessingh Research & Development: Integrating chronic obstructive pulmonary disease exercise coaching into a body parameter controlled game. - Designing a serious game - Designing user requirements - Patient testing

Student

• Oct 2009 - Jan 2010

Internship at the Institute of Health and Biomedical. Research topic: Friction analysis on synthetic cartilage hydrogels. Lab work, both biochemical and biomechanical. Internship at the Institute of Health and Biomedical. Research topic: Friction analysis on synthetic cartilage hydrogels. Lab work, both biochemical and biomechanical.

Office manager of the Biomedical Engineering educational office

• Jul 2009 - Oct 2009

- Editor and writer for the BME study guide.- Secretary/Administrator for the program.- Personal assistant for the education coordinator.

Student member of the BME education quality committee

• Sep 2005 - Oct 2009

- Organizing and chairing meetings with BME students and teachers.- Creating and processing online inquiries.- Composing evaluation reports.

Student teaching assistant

• Sep 2006 - Dec 2008

Physics courses and self-study sessions.