Quality Assurance Specialist

Route 92 Medical Inc•West Jordan, UT

3d•Hybrid

About The Position

This position will support Route 92 Medical's efforts to sustain a best practice Quality System by ensuring compliance to regulatory requirements (13485:2016, MDSAP, EU MDR 2017/745) as well as ensuring products meet all applicable internal and external requirements and specifications. This is an onsite role in our West Jordan, Utah facility - on a hybrid work schedule once proficiency is reached.

Requirements

Adaptable to a fast-paced environment
Professional expertise, ability to apply company policies and procedures to resolve issues.
Attention to detail and focus on the identification of potential issues and continuous improvement
Experience with Salesforce based eQMS systems, Dropbox, Adobe, and Microsoft (PowerPoint/Word/Excel).

Responsibilities

Collaborate with cross-functional teams to address quality issues, drive improvements, and provide guidance.
Coordinate, plan, and perform internal audits and audit corrective actions.
Coordinate and verify corrective & preventive actions (CAPA).
Coordinate and verify nonconforming material activities (MRB) and Quality Events (QE).
Training coordinator responsibilities include generating, maintaining, and executing as required.
Support Document Control as needed.
Support Supplier Management activities
Support intake of complaints
Generate and/or update QMS documentation, such as: Standard Operating Procedures, Work Instructions, Product documentation
Support maintenance of Technical Documentation and Design History Files.
Supports implementation of opportunities for improvement.
Other Quality System activities as required.
Excellent communication and cross-functional teamwork abilities.
Knowledge and Experience of regulatory requirements and quality management systems.