Director of Quality
At Globus, we move with a sense of urgency to deliver innovations that improve the quality of life of patients, inspired by the surgeons and healthcare providers who treat them.
Our world-class engineering works to transform clinical insights into tangible musculoskeletal solutions. We are constantly in pursuit of better patient care, and we understand that speed is critical because life cannot wait. Join us!
The Director of Quality is responsible for providing leadership in achieving the highest level of manufacturing quality of medical devices and quality system performance while ensuring compliance with all company policies and procedures, in addition to leading and enforcing regulatory compliance with US FDA, State, OSHA, and international medical device regulations and ISO 13485 quality system requirements. The Director of Quality will ensure alignment with corporate strategic goals and objectives, foster an environment of team development using coaching and mentoring, lead facility compliance, and implement quality improvement initiatives using Lean Six Sigma principles and practices.
The responsibilities of the position include, but are not limited to, the following:
- Managing and leading improvement of the Quality Management System supporting manufacturing process development and manufacturing operations
- Serving as the business Management Representative to maintain a culture of compliance and excellence
- Ensuring the integration of risk management and risk analysis based on ISO 14971
- Ensuring the integration of risk-based thinking throughout business processes to support decision-making
- Providing leadership for business process excellence using Lean Six Sigma principles and practices while maintaining compliance with US FDA, State, OSHA, and international medical device regulations and ISO 13485 quality system requirements
- Working with the management team to establish strategic goals and objectives, organizational alignment, and a results-oriented workforce
- Providing leadership for workforce education and development within Quality Assurance and supporting all business goals and objectives
- Developing, implementing, communicating, and maintaining quality planning supporting ISO 13485 quality system requirements and annual business goals and objectives
- Overseeing QA functions supporting documentation and training, customer feedback, nonconformances, CAPAs, supplier quality management, and QC Inspection and product release
- Managing and maintaining the Company’s internal quality audit program and assessing improvement initiatives resulting from all Quality Audits – internal and external
- Ensuring individual performance and business process performance meets established goals and objectives
- Establishing, following, and improving company procedures as needed to maintain compliance and meet business goals and objectives
- Providing written and oral communication to help ensure an engaged and informed workforce and management team and keep them informed of results
- Adhering to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies. Ensure Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role
- Representing the company in a professional manner and upholding the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties of Globus
In order to be qualified for this role, you must possess the following:
- Bachelor's degree (Engineering, Science, or Business preferred)
- Minimum of 5 years of experience leading Quality Assurance / Quality Systems with expertise in FDA and CE Notified Body inspections
- At least 10 years of progressive experience is needed in QA/QC management in a manufacturing environment, preferably in the medical device industry
- Lean/Six Sigma experience with a proven track record of business performance improvement
- 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 environments such as noise, dust, odors, and fumes
- Direct supervision of quality assurance employees in a manufacturing facility
- Computer proficiency with MS Office and statistical analysis tools
The following skills are preferred:
- Experience with manufacturing process quality, process controls plans and validation, CNC machining and finishing operations, and inspections systems
- US FDA cGMP and ISO 13485 knowledge. Manufacturing plant safety. Multi-discipline assurance background is desired with an emphasis on problem-solving and CAPA Systems.
- ASQ certification or equivalent (CMQ/OE, CSSBB, CQE, Lean Six Sigma). Must be able to make solid decisions that effectively support the business and company policies
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
The physical demands described here are representative of those that must be met by an employee to perform the essential functions of this job successfully. The employee is occasionally required to sit or stand for extended periods of time. The employee must occasionally lift and move up to 25 pounds.
Globus Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.