Globus Medical · 6 hours ago
Director, Quality
King of Prussia, PA
Full-time
Onsite
Lead/Staff, Director/Executive
5+ years expGlobus Medical is dedicated to improving the quality of life of patients with musculoskeletal disorders through innovative solutions. The Director of Quality will provide strategic leadership for the company’s global quality systems, ensuring compliance with regulatory requirements and fostering a culture of quality excellence across various teams and international markets.
Health CareManufacturingMedicalMedical DeviceWellness
Responsibilities
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
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
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
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
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
Qualification
Required
Minimum BS degree or equivalent in Science or Engineering
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
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
Preferred
A relevant post-graduate qualification would be an advantage but not essential
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
Company
Globus Medical
Globus Medical is a musculoskeletal implant manufacturer, driving technological advancements across a suite of spinal products.
1001-5000 employees
H1B Sponsorship
Globus Medical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (24)
2024 (17)
2023 (13)
2022 (8)
2021 (9)
2020 (11)
Funding
Current Stage
Public CompanyTotal Funding
$128.52MKey Investors
Clarus Ventures
2012-08-03IPO
2007-08-23Series E· $110M
2007-02-05Series D· $9.45M
Leadership Team
Norbert Johnson
Vice President - Robotics
Harri Hallila
Managing Director, International Advanced Technologies
Recent News
2025-12-04
Company data provided by crunchbase