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
- 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
- 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.