Seeking a Quality Engineer in the DFW area!Description:The overall goal of the Quality Assurance Associate is to assist with assuring that the company is compliant with Federal regulations and industry standards including, but not limited to, 21 CFR 820 and ISO 13485.Principal duties and Responsibilities: Manage the Document Management Control System Review requests for modifications of controlled documents, assist with assessment of the impact of requested modifications and action the approved modifications Manage the control of external documents Assist with the development of and implementation of internal audits Participate as a team member for CAPA and Risk Management processes Develop and oversee adherence to Good Documentation Practices Develop and oversee adherence to Cybersecurity practices Liaise with product development teams and assist with and/or prepare 510(k) submissions Other assigned responsibilities upon requestQualifications and Requirements: Bachelor’s degree in a natural science or equivalent work experience. Able to work independently and in team environment. Ability to be knowledgeable of the company products and the orthopedic industry. Possess strong analytical and problem-solving skills. Demonstrated accuracy and attention to detail. Demonstrated ability to communicate with others. Working knowledge of and experience with 21 CFR 820 and ISO 13485 requirements preferred. Proficiency with MS Office products, specifically Word and Excel.Top Skills Details:
Quality assurance
Capa
Document control
Risk managment
QMS
Experience Level:Intermediate LevelAbout Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
