Associate Engineer, Quality - Globus Medical, Inc.
West Carrollton, OH
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.
Job Summary :
Designs, implements and maintains quality assurance protocols and methods for processing materials into finished products. Supports the compliance of manufacturing and production processes with internal and external safety, quality, and regulatory standard requirements for worldwide distribution. Inspects, tests and evaluates the precision and accuracy of production processes and equipment. Assists in report production for trend analysis. Upholds the company's quality standards and testing systems to reflect efficiency, reliability and performance.
Essential Functions :
+ Supports product and process changes for qualification and validation requirements, and assists in change implementations
+ Performs quality inspections, ensuring inspection results and documentation support the recommended disposition action
+ Processes actions from quality system feedback such as records review, non-conforming materials reports, corrective action reports, complaints, or audit reports
+ Assists with the Non-Conforming Material program and general Design Control activities such as risk assessment, design verification and validation, as well as sterilization and packaging validation
+ Assists with new quality initiatives, participating in quality system development and procedure writing and review to improve the quality and reliability of products
+ 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.
_Reasonable accommodation may be made to enable individuals with disabilities to perform these essential functions._
Qualifications :
+ Basic proficiency in computer technology including MS Office applications, with analytical and problem-solving skills
+ Able to work efficiently in a team environment
+ Strong attention to detail and good organizational skills
+ Perform duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13485
+ Typically requires a Bachelor’s degree and no previous professional experience
+ Bachelor's degree in an engineering discipline
Physical Requirements:
+ Must be able to lift 50 lbs with or without accommodation
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 in 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.
Job Summary :
Designs, implements and maintains quality assurance protocols and methods for processing materials into finished products. Supports the compliance of manufacturing and production processes with internal and external safety, quality, and regulatory standard requirements for worldwide distribution. Inspects, tests and evaluates the precision and accuracy of production processes and equipment. Assists in report production for trend analysis. Upholds the company's quality standards and testing systems to reflect efficiency, reliability and performance.
Essential Functions :
+ Supports product and process changes for qualification and validation requirements, and assists in change implementations
+ Performs quality inspections, ensuring inspection results and documentation support the recommended disposition action
+ Processes actions from quality system feedback such as records review, non-conforming materials reports, corrective action reports, complaints, or audit reports
+ Assists with the Non-Conforming Material program and general Design Control activities such as risk assessment, design verification and validation, as well as sterilization and packaging validation
+ Assists with new quality initiatives, participating in quality system development and procedure writing and review to improve the quality and reliability of products
+ 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.
_Reasonable accommodation may be made to enable individuals with disabilities to perform these essential functions._
Qualifications :
+ Basic proficiency in computer technology including MS Office applications, with analytical and problem-solving skills
+ Able to work efficiently in a team environment
+ Strong attention to detail and good organizational skills
+ Perform duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13485
+ Typically requires a Bachelor’s degree and no previous professional experience
+ Bachelor's degree in an engineering discipline
Physical Requirements:
+ Must be able to lift 50 lbs with or without accommodation
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 in 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.