Quality Assurance Specialist

About the role

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.

Responsibilities

• Serves as document control administrator.
• Administers InfuSystem’s document review schedule and communicates with stakeholders as procedures are due for review.
• Maintains SharePoint location for publishing of active revisions.
• Tracks documents through all stages of review and approval, maintains accurate records, and follows 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.
• Affords assistance 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.
• Affords assistance in the management, organization, and review of customer responses and inquiries in the shared inbox for recall activity QA inbox for all recall activities.
• Might 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.

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.

Skills

• Rigorous analytical thinking and problem solving.
• Strong work ethic.
• Sound judgment.
• Proven written and verbal communication skills.
• Natural curiosity to pursue issues and increase expertise.
• Pursues and designs 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.
• Collaborates effectively and works selflessly as part of a team.

Benefits

Comprehensive Benefit Package At InfuSystem, we give our employees the tools to succeed both on and off the job. Our generous benefits package provides comprehensive coverage to help you protect your health and earning power and prepare for the future. In addition, we offer perks and programs that help you grow in your career and make InfuSystem a great place to work!

• 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 & LT.
• 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.

Pay

Details on pay are not specified in the job posting.

Schedule

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