Minimum BS degree or equivalent in Science or Engineering. A relevant post-graduate qualification would be an advantage but not essential
Minimum of 5 years of experience is needed within Medical Device Quality Assurance/ Quality Systems with experience in FDA and CE Notified Body inspections
Experience in product quality assurance, process quality, verification and validation
Experience with electro-mechanical medical devices, including software, is desired
ASQ Certification or equivalent formal training and experience is desired. Multi-discipline assurance background is desired. Knowledge of Lean Manufacturing, Six Sigma, and reliability engineering is a plus
Demonstrated knowledge and understanding of the Quality System Regulations (FDA) and standards, ISO 13485, and other related regulations with emphasis in problem solving and CAPA Systems
Computer proficiency with MS Office and statistical analysis tools 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 quality matters
Travel requirements are as needed
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 visi
Benefits
Health insurance
Additional Information
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 Director of Quality provides strategic leadership and oversight of the company's global quality systems, with direct responsibility for Quality Engineering at the Audubon (HQ) site, International Operations Quality, and Sterile Manufacturing Quality. This position ensures compliance with applicable regulatory requirements (FDA QSR, ISO 13485, EU MDR, MDSAP, etc.) and alignment with company objectives for product safety, effectiveness, and continuous improvement. The Director will collaborate cross-functionally with Manufacturing, Supply Chain, R&D, and Regulatory teams to maintain a culture of quality excellence and operational efficiency across all facilities and international markets.
Essential Functions :
Leadership & Strategy
Develop and execute the global quality strategy aligned with company objectives and regulatory requirements.
Provide leadership, mentoring, and development for the Quality Engineering, International Quality, and Sterile Manufacturing Quality teams.
Serve as a senior quality representative in management review, audits, and regulatory inspections.
Drive a culture of accountability, continuous improvement, and proactive risk management.
Quality Engineering
Oversee product quality engineering, including design assurance, process validation, risk management, and post-market feedback.
Ensure robust CAPA, complaint handling, and nonconformance processes.
Lead validation strategy and ensure compliance with ISO 14971, ISO 13485, and 21 CFR Part 820 requirements.
Support new product development and design transfer to manufacturing.
International Operations Quality
Oversee quality system compliance at all international manufacturing and distribution sites.
Ensure adherence to global regulatory requirements including MDSAP, EU MDR, Health Canada, PMDA, and TGA.
Harmonize global quality processes and drive consistency across regions.
Support international audits and coordinate responses to regulatory authorities.
Sterile Manufacturing Quality
Provide oversight of sterilization validation, monitoring, and requalification programs in accordance with ISO 11135 / ISO 11137 / ISO 17665.
Ensure control of cleanroom operations, environmental monitoring, aseptic techniques, and contamination control programs.
Approve sterilization cycles, validations, and deviations.
Support product release and ensure compliance with sterility assurance requirements.
Audits, Compliance & Continuous Improvement
Lead or support internal and external quality audits.
Ensure timely closure of audit findings and CAPA actions.
Implement continuous improvement initiatives to enhance quality system performance and product reliability.
Monitor and report key quality metrics to executive management.
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Globusmedical · Audubon, PA