Globus Medical
Medical Device
Director,Quality
“Director, Quality at Globus Medical. Skills: Quality strategy, Regulatory compliance, Team leadership. Develop global quality strategy. Provide leadership and development for Quality teams”
What You'll Achieve.
Ensure compliance with applicable regulatory requirements; Alignment with company objectives for product safety, effectiveness, and continuous improvement; Maintain a culture of quality excellence and operational efficiency; Ensure robust CAPA, complaint handling, and nonconformance processes; Ensure compliance with ISO 14971, ISO 13485, and 21 CFR Part 820 requirements; Ensure adherence to global regulatory requirements; Harmonize global quality processes and drive consistency across regions; Ensure control of cleanroom operations, environmental monitoring, aseptic techniques, and contamination control programs; Ensure compliance with sterility assurance requirements; Ensure timely closure of audit findings and CAPA actions; Enhance quality system performance and product reliability
Industry & Context.
Problem solving
Required to climb or 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, Travel requirements are as needed
What They're Looking For.
Must Have
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, 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
Nice to Have
A relevant post-graduate qualification would be an advantage, 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
What You'll Do.
Develop global quality strategy
Provide leadership and development for Quality teams
Oversee product quality engineering
Ensure robust CAPA processes
Lead validation strategy
Support new product development
Oversee quality system compliance
Ensure adherence to global regulatory requirements
Harmonize global quality processes
Provide oversight of sterilization validation
Ensure control of cleanroom operations
Approve sterilization cycles
Support product release
Lead internal and external quality audits
Implement continuous improvement initiatives
Monitor and report key quality metrics
How You'll Work.
Team & Collaboration
Collaborate cross-functionally with Manufacturing, Supply Chain, R&D, and Regulatory teams; Serve as a senior quality representative in management review, audits, and regulatory inspections; Support new product development and design transfer to manufacturing; Support international audits and coordinate responses to regulatory authorities; Support product release and ensure compliance with sterility assurance requirements; Lead or support internal and external quality audits; Monitor and report key quality metrics to executive management
Communication Scope
Presentation skills; Ability to train personnel
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