QA Specialist: ISO 13485, CAPA & Internal Audits Lead

Blatchford Group; Miamisburg (OH); On-site; USD 60,000 - 80,000; Full time

Job summary

Blatchford Group is seeking a Quality Assurance Specialist to help maintain the ISO 13485 quality management system and support QA activities across Operations and Quality teams.

The role involves developing QA procedures, performing internal and supplier audits, and leading CAPA investigations. Strong communication, drawing interpretation, and computer skills are essential for success in a fast-paced manufacturing environment.

Qualifications

• Three years' experience desired.
• Training or certifications in auditing, quality engineering, and problem solving desired.
• Experience in medical devices, FDA, and ISO 13485 desired.
• Ability to communicate verbally and in writing.
• Computer proficiency at least intermediate.
• Ability to read mechanical drawings and interpret technical requirements is a plus.
• Experience with inspection equipment, tools and methods.

Responsibilities

• Maintain and support the ISO 13485 quality management system and QA activities.
• Develop and implement QA procedures per ISO 13485 and regulatory standards.
• Support internal and external audits and supplier audits.
• Lead root-cause analysis for CAPA and follow-up investigations.
• Support change management and control of documents and records.
• Assist operations with work instructions and process documentation.
• Collaborate across Engineering, Operations, Purchasing, and Quality teams.

Skills

Quality assurance

Auditing

Problem solving

Communication

Documentation

Tools

Inspection equipment

Job description

Blatchford Group is seeking a Quality Assurance Specialist to help maintain the ISO 13485 quality management system and support QA activities across Operations and Quality teams.

The role involves developing QA procedures, performing internal and supplier audits, and leading CAPA investigations. Strong communication, drawing interpretation, and computer skills are essential for success in a fast-paced manufacturing environment.