Position Summary:
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.
Essential Functions:
- 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.
- Provide written and oral reports to supervisor or other management personnel to keep them informed of activities and results.
- Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies.
- Ensures 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.
- Represents the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties.
Qualifications:
- Requires a bachelor’s degree (science or engineering preferred) and 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 strong 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.
Physical Demands:
The physical demands listed here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- Required to sit; climb or balance; and stoop, kneel, crouch or crawl
- Required to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds
