2150 - 1579 Quality Operations Manager

DeRoyal•New Tazewell, TN

About The Position

DeRoyal, a global medical device manufacturer, is seeking an experienced Quality Operations Manager to lead and improve quality processes within its manufacturing operations in New Tazewell, Tennessee. The role is responsible for product quality, regulatory compliance, and operational excellence, while driving continuous improvement in a regulated manufacturing environment. The manager oversees quality controls across the production lifecycle, complaint investigations and resolution, quality management systems, audit preparation and follow-up, and analysis and reporting of quality and operational data. The role also promotes staff training, works with customers and vendors to resolve quality concerns, maintains raw material specification files, and oversees product labeling and inserts.

Requirements

Bachelor’s degree from a four-year college or university, or a minimum of eight years of relevant experience, or an equivalent combination of education and experience.
Experience in quality systems within a regulated environment.

Responsibilities

Lead quality control processes throughout production, from raw material inspection through final product release.
Collaborate with manufacturing teams to identify and resolve quality issues in real time.
Develop and maintain quality management systems and procedures.
Oversee product complaint investigations, root cause analysis, and corrective actions to prevent recurrence.
Coordinate complaint-resolution resources and communicate 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, addressing findings and implementing 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 quality performance reports.
Drive plant-wide continuous improvement initiatives to improve product quality and operational efficiency.
Facilitate staff training on quality standards, procedures, and best practices.
Implement process improvements based on quality data, feedback, and audit results.
Manage customer complaints and support timely resolution and customer satisfaction.
Work with vendors to resolve quality issues and ensure supplied materials meet company standards.
Build relationships with stakeholders in support of 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.