Quality Assurance Specialist

Blatchford • Miamisburg, OH

12d • 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, and leading investigations for customer complaints and corrective actions. The specialist will also analyze processes for risks and opportunities, support continual improvement initiatives, and collaborate with various departments to enhance quality, safety, and operational efficiency.

Requirements

• 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.

Nice To Haves

• At least three years’ experience is desired.
• Training or certifications desired: auditing, quality engineering, problem solving.
• Experience in medical devices, FDA, and ISO 13485 is desired.
• Ability to read mechanical drawings and interpret technical requirements is a plus.

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 learning management system.
• Perform internal audits and support with supplier and external audits.
• Lead investigation of customer complaints, collaborating with customer service, repair, and quality team.
• Lead root cause analysis, support investigation, follow-up, and reporting for Corrective and Preventive actions (CAPA).
• Analyze processes to identify risks and opportunities, support 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 for continual improvement.
• Support Quality Control activities including First Article Inspection, nonconforming product investigation, calibration, and supplier corrective action.
• Support Operations by developing work instructions, controlling records/documents, and collaborating with engineering and suppliers to support process flow.

Benefits

• The Company is an equal opportunity employer and does not discriminate against employees or applicants on the basis of race, color, religion, gender, national origin, disability, age, genetic information, veteran status or any other characteristic protected by federal, state or local law.
• The Company will make reasonable accommodation to known physical or mental limitations of a qualified applicant or employee with a disability unless the accommodation would impose an undue hardship on our operation.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed