Director of Quality and Compliance

About Us

Globus Medical is a leading innovator in the field of musculoskeletal solutions, committed to improving the lives of patients with musculoskeletal disorders.

Job Description

We are seeking a highly skilled Director of Quality and Compliance to join our team. This role will be responsible for leading the development and implementation of quality systems and procedures, ensuring compliance with regulatory requirements, and fostering a culture of excellence within our organization.

Key Responsibilities:

• Lead the Quality Management System supporting manufacturing process development and operations while ensuring compliance with all regulatory requirements.
• Provide leadership for business process excellence and foster a culture founded upon Lean Management and Six Sigma principles and practices to drive customer value through continuous improvement.
• Serve as the business Management Representative to maintain a culture of compliance and excellence.
• Ensure the integration of risk management and risk analysis based on ISO 14971.
• Ensure the integration of risk-based thinking throughout business processes to support decision-making.
• Work with the management team to establish strategic goals and objectives, organizational alignment, and a results-oriented workforce.
• Provide leadership for workforce education and development within Quality.
• Develop, implement, communicate, and maintain quality planning supporting ISO 13485 quality system requirements and annual business goals and objectives.
• Oversee all Quality functions, including documentation and training, customer feedback, nonconformance CAPAs, supplier quality management, QC Inspection, and final product release.
• Manage and maintain the Company's internal quality audit program and assess improvement initiatives resulting from all Quality Audits internal and external.
• Ensure individual performance and business process performance meets established goals and objectives.
• Establish, follow, and improve company procedures as needed to maintain compliance and meet business goals and objectives.
• Provide written and oral communication to ensure an engaged and informed workforce and management team, keeping them informed of results.
• Maintain a cooperative and motivational attitude with coworkers.
• Perform other tasks as requested by supervisor to meet business goals and objectives.

Requirements:

• Bachelor's degree in Engineering, Science, or Business, preferred. A relevant post-graduate degree or qualification would be an advantage but not essential.
• Minimum of 5 years of experience leading Quality Assurance/Quality Systems with experience in FDA and CE Notified Body inspections.
• At least 10 years of progressive experience in QA/QC management in a manufacturing environment, preferably in the medical device industry.
• Lean and Six Sigma experience with a proven track record of business performance improvement and personnel development.
• Broad knowledge of manufacturing process control and validation.
• Knowledge of measurement systems and inspection process management.
• Understanding of Mil-ISO and other applicable standards.
• Exposure to shop environment, such as noise, dust, odors, and fumes.
• Direct supervision of quality assurance employees in a manufacturing facility.
• Experience with manufacturing process quality process controls plans and validation, CNC machining and finishing operations, and inspections systems, is preferred.
• US FDA cGMP and ISO 13485 knowledge preferred. Manufacturing plant safety.
• Computer proficiency with MS Office and statistical analysis tools is required.
• Multi-discipline assurance background is desired with emphasis on problem-solving and continuous improvement through workforce engagement and development.
• ASQ certification or equivalent, preferred (CMQ/OE, CSSBB, CQE, Lean Six Sigma).
• Must be able to make solid decisions that effectively support the business and company policies.
• Travel requirements are as needed.
• Presentation skills and ability to train personnel in Quality and Regulatory Compliance.

Estimated Salary: $140,000 - $160,000 per year

Salary : $140,000 - $160,000