The Quality Ops Analyst is responsible for day-to-day administration of Quality Assurance programs in support of the company's Quality Management System. Majority of their day will be participating in team meetings and looking at Tableau and Salesforce dashboards and reports to gather, analyze, and report on data. They will be involved in the development, implementation and maintenance of Quality System processes to meet the requirements of US FDA (e.g., 21CFR 820 QSR), ISO 13485), and other applicable quality and regulatory standards. The Quality Ops Analyst works with relevant departments to ensure successful implementation of quality systems and communicates the impact of changes to areas affected to ensure that the changes are integrated into day to day operations. They will coordinate and participate in internal audit activities and key quality initiatives as appropriate.They will also recommend CAPAs and SCARs based on top issues seen from NC activities and supports the compilation of device master records, device history records, training records, CAPA records and other Quality System records.
- Associates or Bachelors degree in Biology or related scientific field
- 1-2 years of quality assurance experience in an ISO 13485 environment
- GREAT communication and a sharp, analytical person
- Experience analyzing or reporting on data within Tableau, Salesforce, or a related QMS
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.