Corporate Quality Engineering Supervisor
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!
Provide leadership in achieving the highest quality level of manufacturing quality and quality system performance while ensuring compliance with all company policies and procedures and maintaining compliance with US FDA and international medical device regulations and ISO 13485 quality system requirements.
As a key contributor to the quality engineering organization, this professional will be a self-motivated and assertive individual. Characterized as an excellent problem solver, this person will thrive in an organization with high expectation levels and play an integral role in developing, maintaining, and improving the quality management system, product quality, and manufacturing process quality.
Responsible for development, implementation, and continual improvement of quality systems and procedures supporting all business processes including, but not limited to, product design and development, manufacturing operations, supplier management, documentation and records, training, quality management, and auditing. Develop, support, maintain, and improve production processes and controls using a foundation of engineering principles, risk management and risk analysis, and statistical quality control methods.
The responsibilities of the position include, but are not limited to, the following:
- Develop, manage, and mentor Quality Engineers to resolve quality or regulatory compliance problems.
- Identify Quality Engineering candidates and guide their education and learning process to become Certified in Quality Engineering.
- Provide Quality Engineering support for all Globus facilities as directed.
- Develop, improve, implement, and standardize best practices for quality and regulatory compliance, including methods and applications for product risk management, process management, process controls, measurement systems analysis, inspection and testing, data analysis, and statistical techniques.
- Coordinate annual GDP and GMP training with Quality and sterile MFG teams.
- Develop, support, and maintain product risk management and risk analysis activities to ensure quality objectives are met.
- Develop, support, and maintain process FMEAs and control plans.
- Support process optimization using design of experiments (DOE) and retrospective data analysis to understand and minimize sources of process variation affecting products. Identify key process input variables and key process output variables.
- Support activities associated with measurement systems analysis.
- Validate manufacturing processes, including activities associated with equipment installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
- Monitor and analyze production information to support risk management and to provide direction for corrective and preventive actions and/or process improvement activities.
- Apply Lean Six Sigma and Business Process Management concepts to eliminate waste, improve throughput, improve quality, and reduce cost.
- Develop, improve, and maintain quality systems and tools for quality tracking, analysis, reporting, problem solving, and process improvement.
- Use concepts of probability and statistical quality control to guide decisions.
- Communicate quality objectives.
- Integrate quality engineering methods to support co-workers and business objectives for product and process quality and problem resolution.
- Establish, follow, and improve company procedures.
- Provide written and oral reports to supervisor or other management personnel to keep them informed of activities and results.
- Maintain a cooperative and motivational attitude with co-workers.
- Perform other tasks as requested by supervisor to meet business goals and objectives.
- Adhere to all Company policies, rules, procedures and housekeeping standards.
In order to be qualified for this role, you must possess the following:
Education: Requires a bachelor’s degree (science or engineering preferred)
Experience: Candidates for this position will have at least 3 years of related progressive work experience with a background in quality engineering, process quality, statistical quality control, and risk management. Experience in the medical device industry preferred. Candidates must be able to work independently and on teams. Candidates must have very good communication, teaching, and mentoring skills.
ASQ Quality Engineering Certification, or equivalent, is required. Computer proficiency with MS Office and statistical analysis tools is required. FDA QSR and ISO 13485 knowledge is highly desired. Multi-discipline assurance background is desired. Knowledge of Lean Manufacturing, Six Sigma, and reliability engineering is a plus. Must be able to make solid decisions that effectively support the business and company policies. Travel requirements are as needed, including international travel.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is occasionally required to sit or stand for extended periods of time. The employee must occasionally lift and/or 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.