Quality Assurance Specialist

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 Quality Assurance Specialist supports with the maintenance, and continual improvement of the Quality Management System (QMS) and associated quality assurance and quality control processes. The role is responsible for maintaining and approving QMS documentation within the defined scope of authority, ensuring that parts, products, and systems consistently meet established quality requirements and comply with company policies, procedures, and applicable regulatory requirements.

This position ensures ongoing compliance with international medical device regulations and standards, including ISO 13485:2016 quality management system requirements, applicable EU medical device regulations, and, where relevant, EU Cells and Tissues regulatory requirements. Responsibilities include monitoring, inspecting, and improving operational processes and products to ensure conformity with defined acceptance criteria and regulatory expectations.

The Quality Assurance Specialist works closely with the Quality Manager, production and operations teams, and cross-functional departments to maintain QMS effectiveness, support regulatory compliance, and drive continuous improvement of quality performance across the organization.

Essential Functions:

Quality Inspections:

• Conduct routine checks and inspections of materials, processes, and finished products to ensure compliance with quality standards and specifications.

• Document and report any deviations or non-conformities.

Process Monitoring:

• Monitor production processes to ensure they are operating within defined parameters.

• Provide feedback to production teams regarding quality issues and areas for improvement.

• Performs preventative maintenance on Quality equipment.

• Support Quality manager with servicing cell activities, e.g. review process records for accuracy, completeness and retention.

• Monitor all temperature and humidity sensors and alert appropriate department of OOS readings. Generate NCRs as required.

• Supports Quality manager with maintenance of QMS

Testing and Analysis:

• Maintain calibration system and ensure gages and equipment are maintained according to specifications.

Documentation and Reporting:

• Maintain detailed records of inspections, test results, and corrective actions.

• Prepare and submit quality-related reports to supervisors and stakeholders.

• Document non-conformances when found.

• Work efficiently to achieve targeted goals as set by management.

• Follow proper safety precautions.

• Supports Quality manager with complaint handling process.

Compliance Support:

• Ensure products and processes comply with regulatory and company standards.

• Support audits by providing documentation and assisting with corrective actions.

• Collaboration and Communication:

• Work closely with other departments to identify and resolve quality-related issues.

• Document and process returned tissue (hct/p) product.

• 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:

• Education: High school diploma or equivalent

• Experience: Experience in quality assurance or control (preferred) working environment and familiar with ISO 13485.

• Excellent verbal and written communication skills

• Attention to detail

• Self-starter

• Advanced critical thinking and problems-solving skills

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.