Corporate QA Manager

Audubon, PA

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 Corporate QA Manager, Audits and Compliance (CQAM A&C) will be responsible for managing the internal and supplier audit team in Audubon, PA and standardizing the auditing program across all Globus facilities.  This individual will help to ensure compliance throughout all Globus facilities by establishing auditing best practices and training aligned with global regulatory requirements and standards for medical devices and HCT/Ps such as U.S. FDA QSR & GTPs, EU MDD/MDR, ISO 13485, Japan PMDA/MHLW, Australia TGA, Brazilian GMPs/ANVISA, and AATB.   

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

  • Developing, managing, and improving the corporate auditing processes supporting internal audits, supplier audits, and other Globus facility audits
  • Managing the corporate auditing team and develop auditor’s skills by coaching and mentoring on best practices
  • Coordinating auditor training and development across Globus facilities
  • Coordinating annual audit schedules across Globus facilities to ensure efficient utilization of resources based on logistics and capabilities
  • Auditing Design History Files (DHF), CE Technical Files, device history records, and other quality system documents and records
  • Writing audit plans, findings, and reports for internal and supplier review
  • Tracking resolution of audit findings resulting from internal and supplier audits; Escalating findings to CAPA system when required to ensure product safety and regulatory compliance
  • Reviewing technical documentation for product release
  • Participating in continuous improvement projects aligned with corporate goals and objectives as directed by management
  • Ensuring files related to areas of responsibility are orderly and complete
  • Maintaining accurate and complete records of work-related tasks, prepare reports, metrics, trends and graphs as needed to keep the team and management informed
  • Providing other department support requested by immediate supervisor
  • Providing written and oral reports to supervisor or other management personnel to keep them informed of activities and results
  • 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:

  • Minimum BS degree or equivalent in Science, Engineering, or Business
  • Minimum of 5 years in a management or supervisory position within a medical device company with a minimum of 3 years of experience as a Quality Auditor; experience as a Lead Auditor is preferred
  • ASQ Certified Quality Auditor or equivalent certification preferred; multi-discipline quality assurance background is desired
  • Ability to interpret FDA, AATB, ISO, EU and other regulatory guidelines/legislation
  • Demonstrated knowledge and understanding of the Quality System Regulations (FDA) and standards, ISO 13485, and other related regulations with emphasis in Quality Auditing
  • Computer proficiency with MS Office is required
  • Must be able to make solid decisions that effectively support the business and company policies
  • Presentation skills and ability to train personnel in auditing standards and practices
  • Domestic and international travel as needed

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 or stand for extended periods of time. The employee must occasionally lift and/or move up to 25 pounds.

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. 

JOB CODE: 1001326