Quality Assurance Specialist

InfuSystem•Lenexa, KS

45d•Onsite

About The Position

The Quality Assurance Specialist will assure the company remains compliant with regulations and internal quality procedures/policies, and supports activities consistent with company quality objectives and company mission statement. This role supports the Quality Management System primarily in the responsibilities as document control administrator.

Requirements

Bachelor’s degree in an applicable field or Associates degree plus 2 years related experience;
Problem Solving - gathers and analyzes information skillfully; Works well in group problem solving situations.
Technical Skills – Proficient in MS office suite with expert knowledge in word; Strives to continuously build knowledge and skills.
Teamwork - Contributes to building a positive team spirit and models teamwork to members.
Strategic Thinking – Follows Management’s strategy to achieve organizational goals while maintaining compliance; Adapts to changing conditions.
Motivation - Must be highly organized and effectively manage time in order to meet deadlines and due dates.
Strong work ethic
Sound judgment
Proven written and verbal communication skills
Natural curiosity to pursue issues and increase expertise
Pursue and design innovative analytical performance metrics
The courage to promote and defend ideas and analyses
Passionate about InfuSystem and serving customers and patients
Strives to make an impact on improving our business processes and results
Exemplary honesty and integrity
Ability to collaborate effectively and work selflessly as part of a team

Nice To Haves

Previous experience in a document control role in an ISO certified organization strongly preferred

Responsibilities

Serves as document control administrator.
Responsible for administering InfuSystem’s document review schedule and communicates with stakeholders as procedures are due for review
Maintains SharePoint location for publishing of active revisions
Track documents through all stages of review and approval, maintain accurate records, and follow up with stakeholders to ensure established deadlines are met.
Liaises with Learning and Development (L&D) to communicate when a procedure has been released for training
Assist in the management of product recall communications by coordinating communication and responses between customers and OEM partners.
Publishes recall notifications to the designated SharePoint central access location
Assists in the management, organization, and review of customer responses and inquiries in the shared inbox for recall activity QA inbox for all recall activities.
May assist with internal and external quality audits by coordinating administrative activities in accordance with the established audit plan. This includes creating and distributing audit meeting notices and entering audit findings into the Quality Management System software..
Other duties may be assigned.