2150 - 1579 Quality Operations Manager

DeRoyal • New Tazewell, TN

2d

About The Position

DeRoyal, a global medical device manufacturer, is seeking an experienced Quality Operations Manager to lead and enhance quality processes within its manufacturing operations in New Tazewell, Tennessee. The role is responsible for product quality, regulatory compliance, and operational excellence, including driving continuous improvement initiatives. The position requires leadership, analytical skills, and experience with quality systems in a regulated environment.

Requirements

• Bachelor’s degree from a four-year college or university, at least eight years of relevant experience, or an equivalent combination of education and experience.
• Experience with quality systems in a regulated environment.
• Strong leadership and analytical skills.

Responsibilities

• Lead quality control processes throughout the production lifecycle, from raw material inspection to final product release.
• Collaborate with manufacturing teams to identify and resolve quality issues in real time while minimizing operational disruption.
• Develop and maintain quality management systems and procedures to improve operational efficiency and product quality.
• Oversee product complaint handling, investigations, root cause analysis, and corrective actions to prevent recurrence.
• Communicate complaint investigation findings and actions to internal departments and external stakeholders as needed.
• Ensure operations comply with FDA Quality System Regulation, ISO 13485, and other relevant standards.
• Lead preparations for and participate in internal and external audits, address findings, and implement corrective actions.
• Monitor regulatory changes and ensure plant practices meet current requirements.
• Analyze production quality, complaint handling, and operational efficiency data to identify trends and improvement opportunities.
• Present findings and recommendations to senior management and participate in CAPA meetings.
• Develop and distribute regular quality performance reports.
• Drive plant-wide continuous improvement initiatives to enhance product quality and operational efficiency.
• Facilitate staff training on quality standards, procedures, and best practices.
• Implement process improvements based on quality data analysis and audit results.
• Manage customer complaints and ensure timely resolution to maintain customer satisfaction.
• Work with vendors to resolve quality issues and ensure supplied materials meet company standards.
• Develop relationships with key stakeholders to support quality and operational goals.
• Maintain raw material specification files and oversee product labeling and inserts.
• Comply with company attendance and tardiness policies.
• Foster positive relationships with co-workers, customers, and company visitors.
• Perform other duties as assigned by the supervisor.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager