Quality Technician - Globus Medical, Inc.
Limerick, PA
About the Job
At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and outcomes of surgery so patients can resume their lives as quickly as possible.
Branch Medical Group, a subsidiary of Globus Medical Inc., manufactures a wide range of implants for spinal and orthopedic applications as well as 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.
Position Summary:
Provide support 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 process quality.
Responsible for development, implementation, and continual improvement of quality systems and procedures supporting, manufacturing operations, supplier management, documentation and records, training, quality management, and auditing.
Essential Functions:
+ Support production risk management and risk analysis activities to ensure quality objectives are met.
+ Support the development and application of 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 the development, implementation, and improvement of production monitoring methods and systems for product inspection and testing.
+ Support activities associated with measurement systems analysis. Support validation of 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.
+ Work with engineers and department personnel to apply Lean Six Sigma and Business Process Management concepts to eliminate waste, improve throughput, improve quality, and reduce cost. Support the development, improvement, and maintenance of quality systems and tools for quality tracking, analysis, reporting, problem solving, and process improvement. Work with Quality Engineers to apply concepts of probability and statistical quality control to guide decisions.
+ Support the activities associated with addressing customer complaint investigations. Communicate and support facility quality objectives.
+ Support internal and external audits. Help to 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.
+ Adheres to all company policies, procedures and housekeeping standards
+ 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 upholds the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties
Qualifications:
+ Minimum of two-year college degree or relevant experiences.
+ Two years of related experiences, ASQ Certified Quality Technician preferred.
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
+ Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus
Our Values:
Our Life Moves Us philosophy is built on four values: Passionate About Innovation, Customer Focused, Teamwork, and Driven.
+ Passionate about Innovation : Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate ab our role in improving the lives of patients by continuously developing better solutions.
+ Customer Focused : We listen to our customers’ needs and respond with a sense of urgency.
+ Teamwork : Working together, anything is possible. We value every person on our team and treat each other with respect. We are accountable to one another and support each other. Together, we make each other stronger.
+ Driven : We pursue our mission with energy and passion. We are nimble, results-oriented and decisive. We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients.
Equal Employment Opportunity:
Globus Medical is an equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin or citizenship. We are committed to a diverse workforce. We value all employees’ talents and support an environment that is inclusive and respectful.
Other Duties:
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.
Branch Medical Group, a subsidiary of Globus Medical Inc., manufactures a wide range of implants for spinal and orthopedic applications as well as 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.
Position Summary:
Provide support 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 process quality.
Responsible for development, implementation, and continual improvement of quality systems and procedures supporting, manufacturing operations, supplier management, documentation and records, training, quality management, and auditing.
Essential Functions:
+ Support production risk management and risk analysis activities to ensure quality objectives are met.
+ Support the development and application of 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 the development, implementation, and improvement of production monitoring methods and systems for product inspection and testing.
+ Support activities associated with measurement systems analysis. Support validation of 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.
+ Work with engineers and department personnel to apply Lean Six Sigma and Business Process Management concepts to eliminate waste, improve throughput, improve quality, and reduce cost. Support the development, improvement, and maintenance of quality systems and tools for quality tracking, analysis, reporting, problem solving, and process improvement. Work with Quality Engineers to apply concepts of probability and statistical quality control to guide decisions.
+ Support the activities associated with addressing customer complaint investigations. Communicate and support facility quality objectives.
+ Support internal and external audits. Help to 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.
+ Adheres to all company policies, procedures and housekeeping standards
+ 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 upholds the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties
Qualifications:
+ Minimum of two-year college degree or relevant experiences.
+ Two years of related experiences, ASQ Certified Quality Technician preferred.
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
+ Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus
Our Values:
Our Life Moves Us philosophy is built on four values: Passionate About Innovation, Customer Focused, Teamwork, and Driven.
+ Passionate about Innovation : Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate ab our role in improving the lives of patients by continuously developing better solutions.
+ Customer Focused : We listen to our customers’ needs and respond with a sense of urgency.
+ Teamwork : Working together, anything is possible. We value every person on our team and treat each other with respect. We are accountable to one another and support each other. Together, we make each other stronger.
+ Driven : We pursue our mission with energy and passion. We are nimble, results-oriented and decisive. We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients.
Equal Employment Opportunity:
Globus Medical is an equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin or citizenship. We are committed to a diverse workforce. We value all employees’ talents and support an environment that is inclusive and respectful.
Other Duties:
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.
Source : Globus Medical, Inc.
