Senior Qa Manager, Audits & Compliance

About Us:
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.
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.

Essential Functions:

• Develops, manages, and improves the corporate auditing processes supporting internal audits, supplier audits, and other Globus facility audits
• Manages the corporate auditing team and develops auditor’s skills by coaching and mentoring on best practices.
• Coordinates auditor training and development across Globus facilities.
• Coordinates annual audit schedules across Globus facilities to ensure efficient utilization of resources based on logistics and capabilities.
• Audits Design History Files (DHF), CE Technical Files, device history records, and other quality system documents and records.
• Writes audit plans, findings, and reports for internal and supplier review.
• Tracks resolution of audit findings resulting from internal and supplier audits. Escalates findings to CAPA system when required to ensure product safety and regulatory compliance.
• Reviews technical documentation for product release.
• Participates in continuous improvement projects aligned with corporate goals and objectives as directed by management.
• Ensures files related to areas of responsibility are orderly and complete.
• Maintains accurate and complete records of work-related tasks, prepare reports, metrics, trends and graphs as needed to keep the team and management informed.
• Provides other department support requested by immediate supervisor.
• Provides written and oral reports to supervisor or other management personnel to keep them informed of activities and results.
• Maintains a cooperative and motivational attitude with co-workers.
• Adheres to all company policies, rules, 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 uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Qualifications:

• Minimum BS degree or equivalent in Science, Engineering, or Business
• Medical Device experience is a MUST
• A 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

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.

Physical Demands:

The physical demands listed here are representative of those that must be met by and 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.
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

Essential Functions:

• Develops, manages, and improves the corporate auditing processes supporting internal audits, supplier audits, and other Globus facility audits
• Manages the corporate auditing team and develops auditor’s skills by coaching and mentoring on best practices.
• Coordinates auditor training and development across Globus facilities.
• Coordinates annual audit schedules across Globus facilities to ensure efficient utilization of resources based on logistics and capabilities.
• Audits Design History Files (DHF), CE Technical Files, device history records, and other quality system documents and records.
• Writes audit plans, findings, and reports for internal and supplier review.
• Tracks resolution of audit findings resulting from internal and supplier audits. Escalates findings to CAPA system when required to ensure product safety and regulatory compliance.
• Reviews technical documentation for product release.
• Participates in continuous improvement projects aligned with corporate goals and objectives as directed by management.
• Ensures files related to areas of responsibility are orderly and complete.
• Maintains accurate and complete records of work-related tasks, prepare reports, metrics, trends and graphs as needed to keep the team and management informed.
• Provides other department support requested by immediate supervisor.
• Provides written and oral reports to supervisor or other management personnel to keep them informed of activities and results.
• Maintains a cooperative and motivational attitude with co-workers.
• Adheres to all company policies, rules, 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 uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third partie

The physical demands listed here are representative of those that must be met by and 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 pound