alexis worobel

quality systems manager

About

Quality management professional with extensive hands-on experience in aerospace, automotive and medical device manufacturing environments from start-ups to industry leaders including multi-state U.S. and global locations. Detail-oriented leader able to provide innovative new ways to tackle daily quality issues. Recognized for being a self-starter and team player that is always approachable and constantly striving to make every process more effective for the company. Strong technological knowledge, always hands-on and ready to take charge, and can manage multiple issues simultaneously and effectively.

Country

united states

City

naugatuck

Industry

automotive

Skill

root cause analysis, lean manufacturing, continuous improvement, iso 13485, quality assurance, quality auditing, leadership, medical devices, fda, quality management, training, product development, as9100, document management, iso 14001, technical documentation, iso/ts 16949, team leadership, team building, ts16949, 8d problem solving, change control, ppap, fmea, clinical trials, clinical research

Experience

quality systems and document control coordinator; lead auditor

precision resource, inc.

2011-7 - 2014-7 · 3 yrs 1 mo

executive assistant

applied spine technologies

2007-7 - 2010-8 · 3 yrs 2 mos

* Managed administrative duties for an office of 25 on-site employees and 7 off-site employees; primary support contact and gate keeper for Executive Team * Worked side-by-side with Quality Department to manage ISO registration and complete and file CAPA documentation * Regulatory assistant/clinical coordinator for the company’s US IDE Clinical Trial * Communicated on a daily basis with the trial’s 22 participating sites * Assisted site coordinators and investigators with the patient selection process * Managed adverse event reporting * Compiled information for FDA submissions * Active participant in FDA audits * Created various SOPs related to the trial’s patient and site data systems

executive administrative assistant

agency on aging of south central connecticut

2006-10 - 2007-7 · 10 mos

* Managed administrative duties for an office of 135 employees; supervised an administrative staff of 4 * Planned locally-publicized agency events, usually with an attendance of over 150 persons per event * Acted as the community liaison for the Executive Director

neurological laboratory assistant; shipping and inventory clerk

anspach companies

2002-5 - 2005-8 · 3 yrs 4 mos

* Assisted world-renowned neurosurgeons in product-testing courses * Performed dye injections on human cadavers * Tested validations of the inventory database for IT department