QA Specialist Position Summary:

Under the general direction of the Quality Manager, this position is responsible for leading and supporting key elements of the Quality Management System (QMS) within the distribution center. This includes managing internal and external audits, corrective and preventive actions, document and change control, nonconformance processes, QA testing activities, equipment calibration, and complaint handling. The QA Specialist acts as a subject matter resource to ensure compliance, drive continuous improvement, and maintain quality system effectiveness.

Key Responsibilities:

Manage multiple Quality Assurance system processes within the distribution center. Lead compliance efforts, maintain required documentation, and develop action plans to resolve gaps or improve processes. Serve as a quality system expert; identify, recommend, and support implementation of process improvements. Update Standard Operating Procedures (SOPs) and manage assigned QMS processes, which may include, but are not limited to: Internal / External Audits Change Management Nonconformance Management CAPA (Corrective and Preventive Actions) Document Control Learning Management System (LMS) Administration Complaint Handling Ensure ongoing compliance of the distribution center by identifying procedural gaps and delivering training to associates across the organization. Facilitate and/or participate in team and review board meetings related to assigned quality systems (e.g., COC, CRB, MRB, PSC). Develop, prepare, and maintain reports and metrics related to assigned systems. Collaborate effectively with cross-functional teams, including those who may not report directly to this role. Ensure technical writing and documentation across the organization meet required quality standards; provide training as needed. Perform all other duties as assigned. Critical Behaviors for

Success:

Employees in this role are expected to demonstrate behaviors aligned with the competency Model, including: Drive for

Results Customer Orientation Demonstration of Core Values Teamwork Innovation & Creativity Communication Problem Solving & Decision-Making Planning and Organization Job Knowledge Education/Certification Requirements:

High School Diploma/GED OR equivalent work experience at the discretion of the

Hiring Manager Experience-Required Knowledge, Skills, and Abilities:

• Ability to read, write and communicate effectively in English. Basic computer skills required, mainly for data entry. Ability to use Microsoft Office programs as applicable. Knowledge of Good Manufacturing Practices (cGMP). Previous QC/QA experience in medical device or similar industry is preferred. Familiarity with sampling plans (ANSI, AQL, etc.) is preferred. Ability to work in a fast-paced environment with limited supervision.

Pay:

$25.00 per hour Expected hours: 40.0 per week

Benefits:

Health insurance Application Question(s): Previous QC/QA experience in medical device or similar industry

Work Location:

In person