Ashley Sewell

Ashley Sewell

Quality Engineer - Product Quality Escalations Medical Device @ Johnson & Johnson

About

Bachelor of Science in Health Science with a focus in Business Administration Skills: -Training and experience in compliance of ISO 13485:2016, Quality Management System Medical Device regulation. -Training and experience in compliance with FDA CFR Title 21, Parts 820 and 803. -Medical Device Directive knowledge and compliance -Subject matter expert in medical device complaints, adverse event reporting, Operation Excellence and training in a quality environment. -Certified trainer to facilitate training during onboarding of personnel. -Demonstrates critical thinking and problem solving abilities under pressure. -Excellent oral and written communication in customer service settings. -Exhibits strong collaboration when working on a team. -Experience creating and processing complaint files with internal program TrackWise, Salesforce, and Sharepoint programs. -Possesses variety of leadership and interpersonal skills. -Knowledge of Joint Commission policies Achievements: Employee Engagement and Success Committee : July 2018 - November 2019 Allergan Certified Trainer : November 2018 - November 2019 Employee of the Quarter : Q4 2018 College of Nursing and Health Sciences Dean’s List : August 2015-May 2017 Vice President of Public Relations, Delta Delta Delta: August 2015–August 2016 Vice President of Marketing, Panhellenic Council: August 2015–January 2016

Country

United States

City

Greater Houston

Industry

Medical Device

Skill

Attention to Detail, Oral Communication, Quality Assurance, Leadership, Customer Service, Data Analysis, Sales, Social Media, Marketing, Data Entry, Healthcare, Microsoft Word, Microsoft Office, Microsoft Excel, Microsoft PowerPoint, Public Speaking, Critical Thinking, Training, Quality System, Regulatory Compliance

Experience

Johnson & Johnson

Quality Engineer - Product Quality Escalations Medical Device

Johnson & Johnson

LinkedIn
2020-6 - Present · 6 yrs 4 mos

Remote

Stryker

Sr Analyst, RAQA Compliance

Stryker

LinkedIn
2019-11 - 2020-5 · 7 mos
Allergan

Senior Product Surveillance Analyst

Allergan

LinkedIn
2018-6 - 2019-11 · 1 yr 6 mos

Austin, Texas

Allergan

Product Surveillance Analyst

Allergan

LinkedIn
2017-6 - 2018-6 · 1 yr 1 mo

Austin, Texas

Explosion Sportswear

Brand Ambassador

Explosion Sportswear

LinkedIn
2015-12 - 2018-1 · 2 yrs 2 mos

Corpus Christi, Texas Area

Corpus Christi Medical Center

Quality Management Specialist Intern

Corpus Christi Medical Center

LinkedIn
2017-1 - 2017-5 · 5 mos

Corpus Christi, Texas Area

Schlitterbahn Waterparks & Resort

Front Desk Associate

Schlitterbahn Waterparks & Resort

LinkedIn
2017-1 - 2017-5 · 5 mos

Corpus Christi, Texas Area

Education

Texas A&M University-Corpus Christi

Texas A&M University-Corpus Christi

LinkedIn

Health Services/Allied Health/Health Sciences, General

2013 - 2017 · 4 yrs

Ashley Sewell's Contact Information

Email

******@***.com

Phone

(**) *** ****

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