Corporate QA Manager

Corporate QA Manager

Medical device manufacturer, DeRoyal, is seeking a Corporate Quality Assurance Manager to lead and support enterprise-wide quality initiatives at our Corporate Headquarters in Powell, TN. This role is responsible for ensuring the effectiveness, compliance, and continuous improvement of our Quality Management System (QMS) across key corporate functions.

The ideal candidate will be a collaborative leader who can drive quality standards, manage critical programs such as CAPA, and partner cross-functionally to ensure regulatory compliance and operational excellence.

Quality System Leadership

Support the Management Representative for corporate functions including:

• Quality Assurance
• Supply Chain Management
• International Operations
• Customer Support
• Human Resources

Ensure QMS processes are established, implemented, and maintained in compliance with applicable standards.

Partner with internal departments to reinforce quality system requirements and best practices.

CAPA & Compliance Management

• Oversee the Corrective and Preventive Action (CAPA) program:
• Assign, log, and track CAPA activities
• Monitor progress and ensure timely completion
• Verify effectiveness of implemented corrective actions
• Ensure resolution of audit findings (internal and external) and quality inspection issues

Data & Systems Oversight

• Lead Data Control and related information system processes
• Collaborate with IT / Information Systems to ensure regulatory and internal compliance
• Ensure validation protocols are defined, executed, and documented appropriately

Training & Communication

• Conduct training on quality system procedures and requirements
• Serve as a key resource for quality-related guidance across departments

Additional Responsibilities

• Manage quality-related questionnaires and inquiries
• Support continuous improvement initiatives

Education & Experience

• Bachelor’s degree required
• OR minimum of 8 years of relevant quality assurance experience
• Experience in regulated environments (medical device, manufacturing, etc.) strongly preferred
• Spanish language skills are a plus

• Strong knowledge of quality systems and regulatory requirements
• Ability to analyze data and apply statistical concepts
• Excellent problem-solving and critical thinking skills
• Strong written and verbal communication abilities
• Proven ability to manage multiple priorities and drive accountability
• Proficient in Microsoft Office (Word, Excel, PowerPoint)

• Be part of a global medical device leader committed to improving patient care
• Collaborate with cross-functional teams impacting quality across the organization
• Drive meaningful improvements in systems, compliance, and operations

If you’re passionate about quality, compliance, and continuous improvement, we encourage you to apply and make an impact at DeRoyal.