Branch Medical Group, part of Globus Medical Inc., a leading musculoskeletal solutions company, manufactures a wide range of implants for spinal and orthopedic applications as well as to design the instrumentation cases that house them.
Our passion, combined with Globus’ world-class engineering, transforms clinical insights into tangible musculoskeletal solutions. We are constantly in pursuit of better patient care and understand that speed is critical because life cannot wait. Join us!
The Quality Engineer is tasked with providing 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.
The responsibilities of the position include, but are not limited to, the following:
- Developing, supporting, and maintaining product risk management and risk analysis activities to ensure quality objectives are met
- Leading, developing, supporting, and maintaining process FMEAs and control plans
- Overseeing process optimization using design of experiments (DOE) and retrospective data analysis to understand and minimize sources of process variation affecting products
- Identifying key process input variables and key process output variables
- Assisting in the development, implementation, and improvement of production monitoring methods and systems for product inspection and testing
- Validating manufacturing processes, including activities associated with equipment installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ)
- Monitoring and analyzing production information to support risk management and to provide direction for corrective and preventive actions and/or process improvement activities
- Addressing customer complaints by conducting investigations
- Applying Lean Six Sigma and Business Process Management concepts to eliminate waste, improve throughput, improve quality, and reduce cost
- Developing, improving, and maintaining quality systems and tools for quality tracking, analysis, reporting, problem solving, and process improvement
- Utilizing concepts of probability and statistical quality control to guide decisions
- Communicating quality objectives
- Integrating quality engineering methods to support co-workers and business objectives for product and process quality and problem resolution
- Performing internal and external audits
- 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 uphold 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 or Science related field preferred
- Minimum four years of progressive work experience in quality assurance with a background in quality engineering, process quality, statistical quality control, and risk management.
- Minimum two years working in a quality engineering position
- Strong knowledge of GMP and ISO regulations
- Experience with MS Office and statistical analysis tools
- Knowledge of Lean Manufacturing, Six Sigma, and reliability engineering is a plus;
- ASQ certifications preferred
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.
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.