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Sr Manufacturing Operations QA Director

Sr Manufacturing Operations QA Director

CompanyMedtronic
LocationOrange, CA, USA, Irvine, CA, USA
Salary$211200 – $316800
TypeFull-Time
DegreesBachelor’s
Experience LevelSenior, Expert or higher

Requirements

  • Bachelor’s degree required.
  • Minimum of 15 years of relevant Manufacturing Quality / Engineering experience with 10+ years of managerial experience, or an advanced degree with a minimum of 13 years of relevant Manufacturing Quality / Engineering experience with 10+ years of managerial experience.

Responsibilities

  • Lead both manufacturing sites towards excellence in product quality and operational excellence, fostering a culture that prioritizes quality and puts patients first.
  • Develop and implement comprehensive training programs to enhance team skills and capabilities.
  • Ensure manufacturing operations are inspection-ready every day by maintaining rigorous quality standards and documentation practices.
  • Collaborate cross-functionally with colleagues in Global Operations & Supply Chain, Strategy & Technology, Supplier Quality, Micro & Sterilization Assurance Regulatory Affairs, R&D, and others to drive Quality and Enterprise Operations strategies.
  • Oversee the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and standards.
  • Lead audit and inspection preparation, resolving findings, and liaising with auditing groups and inspectors.
  • Create a culture of continuous learning across areas of responsibility, identifying root causes of quality issues and institutionalizing organizational learning.

Preferred Qualifications

  • Experience in Medical, Pharmaceutical or highly regulated product industry.
  • DMAIC Lean / Six Sigma Certification and demonstrated experience leading DMAIC Projects.
  • Demonstrated experience leading Kaizen Events and multiple Quality-related functions.
  • Experience with tissue products.
  • Strong leadership, change management, and transformation skills.
  • Excellent communication, interpersonal, and talent management skills.