Responsible for working with Quality Assurance, Regulatory Affairs, Engineering, Manufacturing, and other company personnel to perform Quality Assurance activities.
Works with the team to ensure continued compliance with ISO 13485 and FDA’s Quality Standard Regulation (21 CFR 820).

PRIMARY RESPONSIBILITIES

Assist the Field Report Coordinator in the processing of product complaints, including receipt of information from field personnel, completion of reportability decision trees, completion of risk assessments, and review of build documentation.
Coordination of product returns associated with product complaints and unused product.
Assist with the supplier approval and monitoring program.
Initiate and conduct activities associated with the CAPA system. Includes maintenance of CAPA log and ownership of regular team meetings.
Support internal, external and supplier audits.
Initiate nonconformances and track activities with assignees to closure.
Support periodic management review of quality metrics.
Perform incoming, in-process and final inspections according to schedule.
Perform or outsource equipment calibration.
Review routine change orders for accuracy, effectiveness, compliance, and quality system impact.

ADDITIONAL RESPONSIBILITIES

Remain current with new and changing regulatory requirements, communicate those requirements internally and help implement internal changes as necessary.
Assess new and revised standards, guidance materials and regulations for impact upon procedures and design activity.
Participate in the assessment and development of Quality System procedures, work instructions, and processes to ensure efficiency and best quality practices in the development of products, conduct of clinical trials, and production of devices.
Perform document control activities.
Attend conferences and seminars to understand and extend company awareness of up-to-date activities in the Quality Assurance field.