Quality Operations Manager Come join our team! Global medical device manufacturer, DeRoyal, is seeking an experienced Quality Operations Manager to lead and enhance quality processes within our manufacturing operations in New Tazewell, TN. This role is responsible for ensuring product quality, regulatory compliance, and operational excellence while driving continuous improvement initiatives. The ideal candidate will bring strong leadership, analytical skills, and experience in quality systems within a regulated environment.
Key Responsibilities:- Operational Quality Oversight:
- Lead the implementation of quality control processes throughout the production lifecycle, from raw material inspection to final product release.
- Collaborate with manufacturing teams to identify and resolve quality-related issues in real-time, ensuring minimal disruption to operations.
- Develop and maintain quality management systems and procedures to enhance operational efficiency and product quality.
- Complaint Handling and Resolution:
- Oversee the process for handling product complaints, ensuring timely and accurate investigations and root cause analysis.
- Coordinate resources for effective complaint resolution and implement corrective actions to prevent recurrence.
- Communicate findings and actions taken to internal departments and external stakeholders as needed.
- Regulatory Compliance and Audits:
- Ensure all 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.
- Stay updated on regulatory changes and ensure the plant's practices meet current requirements.
- Data Analysis and Reporting:
- Analyze data on production quality, complaint handling, and operational efficiency to identify trends and areas for improvement.
- Present findings and recommendations to senior management and participate in corrective and preventive action (CAPA) meetings.
- Develop and distribute regular quality performance reports to track progress and highlight areas for attention.
- Drive continuous improvement initiatives across the plant to enhance product quality and operational efficiency.
- Facilitate training programs for staff on quality standards, procedures, and best practices.
- Implement process improvements based on feedback from quality data analysis and audit results.
- Customer and Vendor Relations:
- Manage customer complaints and ensure timely resolution, maintaining high levels of customer satisfaction.
- Work with vendors to address quality issues and ensure the quality of supplied materials meets company standards.
- Develop strong relationships with key stakeholders to support quality and operational goals.
- Additional Responsibilities:
- Maintain raw material specification files and oversee product labeling and inserts.
- Ensure compliance with company attendance and tardiness policies.
- Foster positive relationships with co-workers, customers, and company visitors.
- Perform other duties as assigned by the supervisor.
EDUCATION and/or EXPERIENCE: Bachelor's degree from a 4-year college or university; or minimum 8 years minimum relevant experience; or equivalent combination of education and experience.
