Celestica International Inc.-posted 4 months ago
$161,000 - $252,000/Yr
Full-time • Director
Maple Grove, MN
5,001-10,000 employees

The Director, Global Quality for HealthTech is responsible for the global HealthTech quality team to establish and maintain a quality-first culture across worldwide manufacturing facilities. This involves managing a large global organization, collaborating with customers, suppliers, and partners, and ensuring compliance with regulatory requirements (FDA, ISO, ASQ, RAC). The position is virtual, offering competitive compensation and career growth opportunities. Significant experience with FDA certification processes is required.

  • Develop and implement the global quality strategy in collaboration with regional and site leadership, identifying gaps and creating short and long-term plans.
  • Share best practices across HealthTech teams and host quality forums for issue discussion, decision-making, and plan execution.
  • Establish the HealthTech Quality Strategy (e.g., MDSAP / MDR).
  • Define annual quality objectives and metrics aligned with business priorities, driving quality culture and performance improvements.
  • Oversee the quality management system globally, including industry certifications, customer surveys, operational reviews, and system applications.
  • Cultivate an 'audit-ready' culture and direct the Global Regulatory Compliance Audit Program, ensuring internal audits are effective and findings are tracked to closure.
  • Conduct Quality Management Reviews and training with manufacturing sites and executive management, advising on risks and mitigation plans.
  • Maintain an effective 8D reporting system for quality issues and resolutions, involving cross-functional staff.
  • Manage talent within the Quality team, including hiring and training.
  • Provide program management leadership for special projects and initiatives and guide quality communities and internal teams.
  • 10-12 years in quality management and related functions (Manufacturing Quality, Design Quality, Validation, Quality Assurance, Quality Systems).
  • Minimum 5 years conducting quality audits.
  • Experience with FDA and regulatory inspections.
  • In-depth knowledge of quality management systems and global compliance.
  • Experience in the HealthTech industry.
  • Global and multi-site leadership experience.
  • Experience in driving cultural change for quality awareness.
  • RAC(US), CQA, ASQ, or ISO/RABSQA Auditor Certification.
  • Medical insurance
  • Dental insurance
  • Vision insurance
  • Short and long term disability
  • Life insurance
  • Voluntary benefits
  • 401k plan with company match
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