Quality Assurance Specialist

Overview:

This role will work with a high degree of independence to support the Quality Assurance organization by working on Corrective and Preventive Actions (CAPAs) by assisting with Root Cause Analysis (RCA), following up on open actions, and assuring timeliness of action completion, and effectiveness checks, This role will also coordinate quality events with subsidiaries, training, conduct audits, and other critical QA function as described below.

Responsibilities:

• GxP knowledge with global understanding/application of phase appropriate regulations.
• Oversee CAPA database and assure prompt completion of activities.
• Assist in investigations related to complaints, process, or material investigations.
• Gain oversight of electronic Quality Management System (eQMS) and assures company compliance to procedures.
• Responsible for timely completion and recording of trainings, conduct company training as needed.

Ideal Background:

• Display leadership skills including proven record of being a results driver and being able to collaborate in a cross-functional environment.
• Proven track record managing CAPA processes and facilitating change through process improvements.
• Working knowledge in the principles and the application of quality assurance and compliance within a medical device environment.
• Experience working with Contract Manufacturing Organizations (CMOs) is a plus.
• Experience working with sterile product is preferred.