Quality Assurance Specialist

Blatchford•Miamisburg, OH

13d•Onsite

About The Position

The Quality Assurance Specialist contributes to the maintenance of the ISO 13485 quality management system and supports Quality Control activity and Operations. This role involves developing and implementing quality assurance procedures, ensuring compliance with regulatory standards, performing internal audits, leading customer complaint investigations, and driving corrective and preventive actions. The specialist will also analyze processes for risks and opportunities, support quality control functions like First Article Inspection and nonconforming product investigation, and assist operations with work instructions and document control.

Requirements

At least three years’ experience is desired.
Experience in medical devices, FDA, and ISO 13485 is desired.
Ability to communicate verbally and in writing.
Computer intermediate or better proficiency.
Document management (PTC Windchill), MS Office desktop apps, SharePoint, Teams, server; CSI Syteline Enterprise Resource (ERP)/ Product Lifecycle Management (PLM).
Experience with inspection equipment, tools, and methods.
Ability to read mechanical drawings and interpret technical requirements is a plus.

Nice To Haves

Training or certifications desired: auditing, quality engineering, problem solving.

Responsibilities

Develop and implement quality assurance procedures in accordance with applicable standards (ISO 13485).
Ensure compliance with regulatory standards and customer requirements.
Perform and monitor tasks assigned in organization change management system.
Support managers and trainees with the learning management system.
Perform internal audits and support with supplier and external audits.
Lead customer complaint investigations, collaborating with customer service, repair, and cross-functionally within the quality team.
Lead root cause analysis for Corrective and Preventive Actions (CAPA), support investigations, follow-up, and reporting.
Analyze processes to identify risks and opportunities, supporting areas of business with FEMA and PFEMA.
Undertake tasks or minor projects for quality and safety as assigned.
Develop opportunities and collaborate across functions of Engineering, Operations, Customer Service, Purchasing, Repair, IT, HR, and Quality.
Support Quality Control: First Article Inspection, nonconforming product investigation, calibration, supplier corrective action.
Support Operations: Development of work instructions, control of records/documents, collaboration with engineering and suppliers to support process flow.