Quality Systems Specialist Jobs

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!

Position Summary:

The Quality Systems Specialist will be part of the Quality team supporting Globus Medical’s Product Development and Manufacturing Operations to help drive continuous improvement in the Quality Systems Procedures, and Processes, and to help improve existing and future Product Quality. The job requires an individual who is a team player with the ability to function well in a challenging and fast paced environment. Must be positive, even tempered and have strong skills in areas of dependability, flexibility and maturity.

The responsibilities of the position include, but are not limited to, the following:

• Define and perform effectiveness checks, as appropriate
• Providing day-to-day support in the site complaint-handling processes from intake to closure through timely follow-up, assessment, processing, investigation, coding, and documentation of customer complaints in compliance with company procedures, government regulations and standards
• Ability to lead cross-functional teams to establish problem statements and root cause analysis through industry accepted investigational & Root Cause Analysis techniques
• Assists in the generation of and maintenance of documentation for the complaint system
• Identify, implement and maintain systems to assure that training records for site personnel are complete, accurate, and compliant to company processes
• Provide input into KPI monthly metrics
• Facilitate regular cross-functional meetings to ensure CAPAs are being reviewed and addressed in a timely fashion and in accordance with the company goals and regulatory requirements
• Maintain established training matrix defining procedural training requirements
• Review CAPA activities to ensure compliance with internal processes and procedures
• Provide support on change control activities
• Training Coordinator including
  • Work in partnership document control and department managers to develop and maintain training requirements for site activities
  • Maintain established training matrix defining procedural training requirements
  • Maintain metrics related to the efficiency and effectiveness of training activities
  • Identify, implement and maintain systems to assure that training records for site personnel are complete, accurate, and compliant to company processes
• Maintain metrics related to the efficiency and effectiveness of training activities
• Responsible for coordinating site CAPA activities by performing the following:
  • Facilitate regular cross-functional meetings to ensure CAPAs are being reviewed and addressed in a timely fashion and in accordance with the company goals and regulatory requirements
  • Facilitate appropriate CAPA owner assignment by working with department managers to ensure resources have been appropriately assigned.
  • Ensure the appropriate completion of assigned task by owners.
  • Review CAPA activities to ensure compliance with internal processes and procedures
  • Ability to lead cross-functional teams to establish problem statements and root cause analysis through industry accepted investigational & Root Cause Analysis techniques
  • Provides subject matter expertise, leadership and training on investigational & Root Cause Analysis techniques, as appropriate, to other CAPA team members and to technical subject matter experts involved in the resolution of quality issues
  • Define and perform effectiveness checks, as appropriate
  • Maintains the effectiveness of the CAPA system records to ensure audit-readiness for internal and external quality system audits
• Work in partnership document control and department managers to develop and maintain training requirements for site activities
• Provides subject matter expertise, leadership and training on investigational & Root Cause Analysis techniques, as appropriate, to other CAPA team members and to technical subject matter experts involved in the resolution of quality issues
• Collaborate with departments to ensure other Quality System activities are effectively completed including:
  • Support site internal audit activities
  • Provide input into KPI monthly metrics
  • Provide support on change control activities
  • Provide support in other areas, as needed
• Responsible for coordinating site Complaint activities by performing the following:
  • Providing day-to-day support in the site complaint-handling processes from intake to closure through timely follow-up, assessment, processing, investigation, coding, and documentation of customer complaints in compliance with company procedures, government regulations and standards
  • Facilitate appropriate Complaint owner assignment by working with department managers to ensure resources have been appropriately assigned
  • Assists in the generation of and maintenance of documentation for the complaint system
• Maintains the effectiveness of the CAPA system records to ensure audit-readiness for internal and external quality system audits
• Facilitate appropriate CAPA owner assignment by working with department managers to ensure resources have been appropriately assigned.
• Provide support in other areas, as needed
• Facilitate appropriate Complaint owner assignment by working with department managers to ensure resources have been appropriately assigned
• Ensure the appropriate completion of assigned task by owners.
• Support site internal audit activities

In order to be qualified for this role, you must possess the following:

Bachelor's degree in Business, Engineering or related discipline preferred.

• 2-5 years minimum regulated industry experience in medical device in a Quality Assurance role.

• Excellent interpersonal skills with the ability to serve as a liaison with developers, project managers, and customer support.
• Understanding of ISO/QSRs and the ability to apply the knowledge to the business and ensure compliance of regulations
• Proficient with Microsoft Office Suite or related software.
• Ability to resolve problems using various problem-solving methodologies, including strong investigation and root cause analysis skills
• Excellent organizational skills and attention to detail
• Experience providing guidance to cross-functional teams preferred.
• Position requires critical thinking skills and applied knowledge of industry accepted investigational & Root Cause Analysis techniques
• Ability to work under minimum supervision with a high degree of organizational and technical competence

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.

Physical Demands:

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; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

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.