JOB DESCRIPTION :
The function of Senior Quality Engineer is to provide direction and leadership within the Regulatory Compliance group, CAPA system, problem solving and decision making, to ensure that the quality system is in compliance with the established requirements.
The Sr. Quality Engineer ensures the organization maintains compliance with US and foreign regulation requirements and provides constructive evaluation of quality related systems.
Their leadership in the area of GMP compliance will assure that activities are performed and documented per our systems and procedures in accordance with Abbott policies and applicable quality and regulatory requirements intended to assure the effectiveness and safety of our products.
Responsible for leading a group which is compliant with applicable Corporate and Divisional Policies and procedures.
The responsibility of this function is to lead a team which assesses the compliance of systems and facilities per applicable regulations.
This is executed through managing the following activities :
CAPA System Subject Matter Expert, identify improvement, including teach and manage certification of CAPA Users at all levels (As needed)
Conduct investigation and able to judge the quality of investigations based on technical knowledge, tracks issues through to closure including reviewing the corrective action taken
Problem solving and decision making for investigations
Audits areas of AVCR and Abbott Vascular quality system, which includes Internal Audits execution and responsible for coordination of external audit support, including assessment and management of Audit findings (nonconformities).
Implements a staffing plan by identifying resource requirements, writing justifications for additional personnel, obtaining approval for changes, and coordinating the selection process with Human Resources. (As needed)
Develops direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate and conducting formal written and verbal performance reviews.
Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations etc).
Participates on Divisional Compliance Teams for coordination of site activities and provides direction to site audit team
Bachelor Degree. License Degree (Licenciatura) preferred.
Engineering or other technical / scientific or industry experience (>
6 years or equivalent work experience) with sufficient exposure to medical device or related industries.