Qualification / Experience:

• MBA is a plus Experience:
• Bachelor’s degree required in a science, engineering field or related discipline.
• 10 years of QMS experience and demonstrated leadership experience.
• Proficiency with ISO 13485, Good Clinical Practices (GCP), and Quality SystemInspection Techniques (QSIT); CFR’s parts 210 &211.
  

Skills & Abilities:

• Strong understanding of global registration requirements and demonstrated trackrecord of successful market access.
• Extensive experience hosting regulatory inspections and interacting with regulators
• Experience with computer software validation (CSV) and implementation for QMSand ERP software packages, including user requirements gathering and specificationdevelopment, process workflow documentation, validation script writing, and IQ/OQ/PQ test case execution
• General understanding of ICH, cGMP, cGDP, FDA, ISO, MDR, Healthcare compliance and applicable regulations and industry standards regarding clinical research and regulation of medical devices
• Effective manager with ability to mentor and develop members of the QA/RAteams through coaching and effective performance management

Responsibility:

• Proven track record with establishing and maintaining strong internal and external partnerships.
• Proven ability to create culture of accountability and ownership
• Must be able to work effectively at all levels in the organization in a matrix environment and with external partners.
• Must demonstrate excellent written and verbal communication skills and work well with diverse teams and stakeholders in multiple locations.
• Must possess the ability to conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities to meet deadlines and prioritize work on multiple projects.
• Highly independent and self-motivated and integrates well within a team. Physical Demands
• Ability to travel.