The Senior Director of Quality will be responsible for overseeing operational quality across multiple manufacturing sites, driving conformance, corrective and preventive actions (CAPA), and quality control (QC) initiatives.
The role will focus on minimizing Class I recall costs, enhancing quality systems, and building a culture centered on high-quality outputs.
This leader will oversee electro-mechanical and chemical components manufacturing processes while centralizing quality systems across four sites.
Key Responsibilities::
- Ensure conformance across all manufacturing processes.
- Lead and improve Corrective and Preventive Actions (CAPA) to address quality issues.
- Oversee Quality Control (QC) processes to drive consistent product excellence.
- Minimize recall costs and manage Class I instrument recalls integrated with assay processes.
- Directly manage Managers of Reagents and Instruments.
- Provide leadership to 12+ indirect reports across multi-site operations.
- Drive team accountability and alignment with quality priorities.
- Oversee the integration and simplification of quality systems across four manufacturing sites.
Requirements:
- 10+ years of experience in Quality Assurance or Regulatory Affairs in a cGMP Medical Device environment.
- 5+ years of leadership experience in complex quality assurance and quality systems.
- Proven ability to lead teams through influence, coaching, and innovative practices to instill a culture of compliance, ownership, and continuous improvement.
- 5+ years of demonstrated expertise in: IEC 61010, IEC 61326, IEC 60601, and IEC 62304 standards.
- Extensive experience with ISO 13485, ISO 14971 standards.