"Alerted.org

Job Description:

+ Client is seeking a highly skilled and experienced eQMS Administrator who will play a crucial role in establishing new eQMS software to support digital health application and medical device product development.

+ Individual will ensure compliance with industry regulations and standards, playing a key role in the implementation, maintenance, and retirement of eQMS software.

Responsibilities:

+ Work closely with the Quality team to execute user acceptance test cases for validation of new eQMS software.

+ Responsible for administrative controls, system configurations, periodic system upgrades, and continuous improvement efforts of the eQMS, as needed.

+ Work with software vendors and internal cross functional teams to ensure systems are appropriately validated, implemented, and maintained in accordance with current industry practices.

+ Provide CAPA, audit, and overall QMS support in regard to software.

Mandatory Skills:

+ Working knowledge of GxP regulations Strong technical knowledge of GMP and/or GCP regulations and eQMS systems; experience with ArenaPLM administration strongly preferred.

Desired Skills:

+ Comfortable with Google Apps for Work applications.

+ Proven ability to handle ambiguity and work collaboratively with internal and external cross-functional teams.

+ General experience with user acceptance testing in medical device/pharmaceutical environments **.**

Education:

+ Associate or Bachelor’s degree in related technical field or equivalent practical experience (3+ years working experience with Associates, 1+ year with Bachelor’s) 4+ years of work experience, preferably in a regulated industry, e.g., medical device, pharmaceutical under good clinical, laboratory, manufacturing, and distribution practice (GxP) environments.

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com (http://www.ustechsolutionsinc.com/) .

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.