JOB DESCRIPTION :
The function of Senior Quality Engineer (Compliance) is to provide direction and leadership within the Compliance, Product Release, and Supplier Quality Assurance Departments.
The Sr. Quality Engineer of Compliance 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.
Core Job Responsibilities
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 :
The Senior Quality Engineer of Compliance is identified as knowledgeable and a leader within the division for matters pertaining to the Quality Assurance activities associated with Good Manufacturing Practices (GMP).
The position serves to determine if facilities, systems and procedures are in accordance with
established requirements / standards and assure that products are effective and safe for their intended use.
The Senior Quality Engineer of Compliance leads a team of Supplier Quality Engineers and Incoming Inspectors focused on driving improvement and corrective action in the quality of components sourced from outside supplier s.
The Senior Quality Engineer of Compliance provides technical support in the selection of supplier s, supports the development of acceptance criteria for materials, and monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures.
The Senior Quality Engineer of Compliance leads the quality assurance product release team whose role is to ensure that all units, either commercial or clinical product, have been manufactured and released in accordance with internal procedures prior to release.
The position serves a strategic purpose for Abbott and must achieve a difficult balance of involvement and objectivity, perform risk analysis, and prioritize key issues for GMP compliance.
The auditing function serves to provide feedback in the form of audit observations, formulate recommendations and determine if corrective actions and commitments have been properly implemented, proven to be effective and are being maintained.
The position also provides an active role within the Corporation as Divisional experts in GMP requirements. The key strategic focus is for early detection and prevention, followed by correction of issues.