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 Senior Manager, CAPA (Corrective and Preventive Actions) and Complaints is responsible for leading the investigation, resolution, and continuous improvement of quality-related issues related to customer complaints and regulatory compliance. This role ensures that CAPA and complaint processes comply with FDA, ISO 13485, MDR, and other global regulatory requirements while driving operational excellence.

Essential Functions:

CAPA Management:

Oversee the end-to-end CAPA process, ensuring timely identification, investigation, and closure of corrective and preventive actions

Lead root cause analyses (e.g., 5 Whys, Fishbone Diagrams, FMEA) to identify systemic issues

Ensure CAPA effectiveness checks are conducted and documented per regulatory requirements

Complaint Handling & Investigation:

Manage the customer complaint process, ensuring timely intake, investigation, and resolution

Coordinate cross-functional teams (Engineering, Quality, Regulatory, and Manufacturing) to investigate complaints and implement corrective actions

Ensure MDR/IVDR and FDA 21 CFR 803 compliance for reportable events

Regulatory Compliance & Audits:

Ensure CAPA and complaint processes align with FDA, ISO 13485, EU MDR, and other global regulations

Serve as SME (Subject Matter Expert) during regulatory audits and inspections

Maintain compliant and CAPA metrics for Management Review and continuous improvement initiatives

Process Improvement & Training:

Develop and enhance CAPA and complaint handling SOPs, work instructions, and training materials

Provide training and mentorship to internal teams on effective investigation techniques and documentation best practices

Drive continuous improvement initiatives to optimize efficiency and compliance

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:

Bachelor’s degree in Engineering, Life Sciences, Quality, and/or related fields; Master’s degree preferred

Minimum 7-10 years of experience in medical device, pharamaceutical, or biotechnology industries with a focus on CAPA and compliant handling

Strong understanding of FDA 21 CFR 820, ISO 13485, EU MDR, and global quality system regulations

Expertise in CAPA investigations, root cause analysis (RCA), and risk management (ISO 14971)

Experience with electronic QMS (eQMS) systems (e.g., EtQ, TrackWise, MasterControl, Veeva)

Strong analytical, communication, and leadership skills

Excellent verbal and written communication skills

Attention to detail

Self-starter

Advanced critical thinking and problems-solving skills

Physical Demands:

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

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.