The Senior Manager, Quality Systems manages day-to-day operations of the Quality Systems team including other managers; provides directives to the entire department and serves as a subject matter expert for quality systems processes.
Minimum Work Experience/Educational Requirements:
• Bachelors degree in a technical discipline; Master's degree preferred
• 10+ years experience in quality systems
• 5+ years experience in FDA-regulated industry
• 3+ years management experience
• Knowledge of medical device regulations, pertinent standards and guidances
• Knowledge of quality tools & principles
• Proven written and verbal communication skills
• Basic knowledge of statistics
• Proven problem solving skills
Physical Requirements/Work Environment:
• Works under general office environmental conditions
• Sitting for extended periods, utilizes close visual acuity for working with computers, equipment, etc.
• Some travel involved
Employee signs a non-competition and confidentiality agreements in relation to his/her employment with Cook. Employee acts in compliance with company policies including but not limited to, the Cook Employee Manual, Cook Code of Conduct, Cook Electronic Information Policy, Product Complaints, Privacy regulations and Cook Policy & Guidance On Interaction with Healthcare Professionals.