Project Leader - Food Safety – Quality Assurance (QA)
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.
MAIN PURPOSE OF ROLE
The Project Leader will assure high quality products through initial design, incoming materials used to manufacture and/or product manufactured by a third party as determined by assigned functional area.
- Ensure that quality procedures meet the most current requirements and are in alignment with corporate policies and procedures.
- Participate in and provide input for the on-going review of key performance indicators or other sources of quality data to ensure that performance is monitored, and the corrective action is taken as required.
- Design Assurance: Ensure product or product designs provide necessary safety, efficacy, regulatory compliance and customer satisfaction while balancing the need for speed to market as well as cost effectiveness. Ensures manufacturability of new formulations and products to commercial scale up by working with R&D, Technical Centers and manufacturing sites (internal and external).
- External Quality: Assure the high-quality supply of incoming materials and/or products through evaluation and development or suppliers and third-party manufacturers. Work with suppliers or TPMs as part of an ongoing supply management process to support qualification, performance monitoring and continuous improvement processes. Support plant quality assurance, operations, logistics and/or purchasing groups globally to ensure that proper documentation involving CAPA, testing/release, acceptance plans and specifications are compliant to Corporate and regulatory requirements.
- Prepares Quality documents and assures appropriate design review is conducted.
- Monitors product, process, package quality performance of assigned area and identifies quality related issues and trends.
- Works with functional peers, operations or external partners to develop and implement corrective actions.
- Works on problems where analysis of situation or data requires review of defined factors to assure that there are no negative or adverse impacts to in process or finished product as a result of implemented controls
- Exhibits high level of technical competence in data analysis and product related calculations.
- Collaborates across the technical portion of the organization
- Identifies/gains agreement on design criteria, negotiates solutions, balances quality with other criteria across all functional areas.
- Displays working knowledge of relationships between regulations, labeling, process and product. Encounters differing but recurring problems and/or duties.
- Displays working knowledge of global country regulations and policies related to Abbott’s products and assures products meet applicable regulations.
- Track and trend, monitor, and report applicable metrics on a monthly, quarterly or annual basis for assigned area as required.
Bachelor’s Degree – Engineering or equivalent combination of education and work experience
- Minimum 3 years
- Experience in a regulated industry and experience in the scale- up and commercialization of product innovations.
- Experience in performing audits and working independently when troubleshooting internal or external issues.
- Ability to provide technical expertise, consultation and recommendations to internal and external customers to improve product performance and quality assurance principles.
- Ability to successfully interact and communicate with all organizational levels internally and externally (e.g. suppliers or external regulatory bodies).
- Demonstrated ability to manage several activities / projects at once, organize /prioritize work.
Our company is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, veteran status, gender identity or expression, or any other basis protected by local, state or federal law.
This policy applies with regard to all aspects of one’s employment, including hiring, transfer, promotion, compensation, eligibility for benefits and termination.