Quality Manager MES - JBL Resources

MES Quality Manager
Location: Elkton, Maryland
About Our Client:
Our Hiring Company, a best-in-class Medical Device Manufacturer has an opening for a new team member at their facility.  Holding itself to the highest standards of integrity, quality and excellence, this company has contributed to the healthcare industry for over 90 years and has been rated as Forbes top 14 most innovative companies in the world. With a strong vision for making medical treatments easier on its patients, this company gears its technological innovations from its top-talented engineers towards making a significant contribution to our society.
Key Responsibilities:

• Managing the quality aspects of Manufacturing Execution Systems (MES), ensuring that the systems comply with regulatory requirements and quality standards.
• Overseeing the implementation, validation, and continuous monitoring of MES systems.
• Leading the validation process for MES systems, including protocol development, execution, and documentation.
• Ensuring that MES systems adhere to FDA, ISO 13485, and other relevant regulations and standards.
• Developing and implementing quality assurance processes for MES-related activities.
• Monitoring and evaluating system performance to identify areas for improvement and ensure that quality metrics are met.
• Investigating and resolving MES-related quality issues, including system deviations, non-conformances, and customer complaints.
• Coordinating with IT, engineering, and production teams to implement corrective and preventive actions (CAPAs).
• Driving continuous improvement initiatives within the MES framework to enhance system reliability, accuracy, and efficiency.
• Utilizing data analysis and performance metrics to identify trends and areas for optimization.
• Working closely with IT, production, engineering, and quality assurance teams to ensure that MES systems are effectively integrated into manufacturing processes.
• Facilitating communication and coordination to address and resolve quality-related issues.
• Maintaining comprehensive documentation related to MES quality management, including validation records, compliance reports, and quality metrics.
• Preparing and presenting reports to senior management and regulatory authorities as needed.
• Providing training and support to team members on MES quality standards, procedures, and best practices.
• Ensuring that staff are knowledgeable about MES systems and their role in maintaining quality.

Qualifications:

• Bachelor’s degree in Engineering, Engineering Technology, Computer Science, or a relevant field required.
• 8 years of Engineering experience with a strong focus on Manufacturing Execution Systems (MES) and quality assurance within the medical device or healthcare industry.
• Proven experience in MES validation, system implementation, and continuous improvement processes.
• Minimum 2 years’ experience supervising a team is preferred.
• Experience working in a manufacturing environment preferred.
• Experience with change management, computer system validation, and HP ALM, preferred.
• Strong hands-on experience with manufacturing processes/ documentation – BOMs, control plans, training materials, etc.
• Detail-oriented with strong organizational skills and the ability to manage multiple projects and deadlines.

Interested Candidates please apply on our website at https://jobs.jblresources.com.
For more information about our services and great opportunities at JBL Resources, please visit our website: https://www.jblresources.com.
JBL Resources is proud to have earned the reputation of being a premier provider of top talent professionals in the fields of engineering, human resources, logistics, operations, and supply chain management. As specialists in both permanent placement and contract services, our mission is to help companies and individuals become all they were created to be.
**JBL is an Equal Opportunity Employer and E-Verify Company