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Quality Systems Manager at Intuity Medical
Fremont, CA, US

Position Summary:

The Quality Systems Manager is responsible for managing the quality management systems functions of Intuity Medical on a day-to-day basis to ensure regulatory compliance.

Duties and Responsibilities:

  • Provide leadership and management through guidance and interpretation of regulatory requirements to Quality department staff, including providing support as Deputy Management Representative.
  • Assure accuracy and completeness of Quality System documentation and procedures in accordance with relevant regulations 
  • Manage quality activities in line with the company’s expectations and department objectives working within a defined budget
  • Manage the Quality Internal Audit Program
  • Ensure materials and products conform to quality specifications during incoming inspection, in-process manufacturing, and final product release. Provide managerial oversight to QC Inspection area.
  • Maintain current knowledge of industry standards and regulation requirements for products developed
  • Audit Design history files for new products for FDA compliance, if needed
  • Participate in third-party regulatory audits when necessary. Manage external FDA and ISO audit schedules, correspondence and closing of findings
  • Participate in the risk management program
  • Ensure appropriate application of statistical tools in meeting specifications and regulatory requirements

Required Skills:

  • 8+ years of successful experience with medical device companies preferably in the glucose monitoring industry. At least 3 years of management experience.
  • Working knowledge of regulatory requirements such as QSR, ISO13485, and IVDD
  • Ability to lead and coach diverse team members in achieving department effectiveness
  • Strong collaboration, team building, and development skills
  • Ability to analyze diverse scientific and regulatory issues
  • Strong written, verbal and interpersonal skills
  • Prior experience working in emerging, start-up companies desired
  • Strong statistical application experience a plus

Minimum Education:

  • The preferred candidate will have a minimum of a bachelor’s degree in sciences, engineering or related field
  • ASQ CQE (Certified Quality Engineer), CQA (Certified Quality Auditor) or other relevant certification is desirable.