Assist with the maintenance of quality systems and facilitate continuous quality improvements. This position is responsible assisting with the maintenance and monitoring of a variety of cGMP documentation including complaint files, complaint processing system, Medical Device Reporting, corrective action and preventive actions (CAPA), and maintenance of other related quality system records as required.
Essential Duties and Responsibilities:
· Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures
· Ability to work in an environment with multiple short-term deadlines, frequent interruptions and changing priorities.
· Review and evaluate complaints per Standard Operating Procedures.
· Analyze adverse incident factors under supervision. May assist determining if events must be reported to Regulatory Authorities
· Document and maintain records of all complaint investigations in accordance with domestic and worldwide international regulations (e.g. 820, MDD, ISO, and other countries).
· Complete all required customer complaint related documentation in an accurate, professional and timely manner. Contribute high quality work.
· Contribute to the development and implementation of procedures that ensure quality standards are met.
· Support projects that further the improvement and efficiency of the department
· Support internal, external, and third-party audits.
· Perform routine complaint system data entry, documentation, and administrative tasks.
· Able to work flexible hours, including evenings, holidays and weekends. Overtime may be required.
· Perform other duties as assigned
· 0 to 2 years related experience preferably in medical device post-market product surveillance complaint handling or equivalent combination of education and experience.
· Strong analytic ability is required.
· Basic computer software skills, i.e. Microsoft Office.
· Knowledge of and experience in field of diabetes and CGM technology is highly desirable.
· Certification(s) for particular engineering/quality discipline.
· Intermediate computer software skills, e.g. MS Excel and MS PowerPoint.
· Preferred Bachelor’s degree from an accredited college or university.