Quality Assurance Specialist

Quality Assurance Specialist

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. This is a hybrid opportunity in our Lenexa, Kansas office with in office days set as Tuesday - Thursday.

In this role, the ideal candidate will:

• Serve 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.

This position has no supervisory responsibilities.

The ideal candidate will have the following qualifications:

• Bachelor's degree in an applicable field or Associates degree plus 2 years related experience;
• Previous experience in a document control role in an ISO certified organization strongly preferred
• 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.

No travel is required.

Personal and professional attributes:

• 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

Physical demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Work environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Comprehensive benefit package:

• Health plan options that include an employer contribution
• Health Savings Account (HSA)
• Healthcare and Dependent Care Flexible Spending Accounts (FSA)
• Dental and Vision premiums covered by InfuSystem
• Life Insurance, STD & LTD
• Paid Parental Leave
• Adoption and Fertility Assistance
• 401(k) with a specified Company Match
• Employee Stock Purchase Program
• Tuition Assistance
• Generous Paid Time Off plan
• Employee Assistance Program
• Competitive Pay
• Employee Referral Bonus