Project Leader Design Assurance

Job Description

Job Description Project Leader Design Assurance. Primary Function / Primary Goals / Objectives:The primary objectives of the Project Leader, Design Assurance, are to assure product designs provide necessary safety, efficacy, regulatory compliance, and customer satisfaction while balancing the need for speed to market as well as cost-effectiveness.The candidate works with their functional group peers and managers to define Design Assurance related deliverables to ensure successful scale-up to commercial-scale manufacturing (successful FLTS process). Together with R&D, Technical Centers and Plant operations, the incumbent assesses critical-to-quality attributes and ensures the manufacturability of new formulations and products. Anticipates conflict in project attributes and operations capability and drives resolution.Major Responsibilities:

• Assures that the design and testing for all Abbott Nutritional products are fully compliant with applicable regulations.
• Facilitates product technical risk management activities through product development stages.
• Reviews, and prepares when appropriate, manufacturing and quality documents related to product manufacture to assure that appropriate design review criteria and nutritional requirements and guidelines are adhered to and complied with.
• Reviews and approves, as needed, technical reports and documents written by R&D and Technical Centers pertaining to product quality and shelf-life.
• Works on problems of complex scope where analysis of situation or data requires a review of defined factors.
• Monitors product, process, and package quality performance and identifies quality-related issues and trends.
• Provide technical reviews and guidance on issues related to product quality and nutrient performance to R&D, Technical Centers and Plant QA.
• Works with and provides direction to functional peers and operations to develop and implement corrective actions for product function-related issues.
• Identify/gain agreement on design criteria, negotiate compromises, and balance quality with other criteria across all functional areas.

• Participates in NPI and/or FLTS project teams, as required, to collaborate and provide leadership and guidance from a technical and quality standpoint.
• Displays a high level of understanding in general food nutrition and knowledge of food ingredients and nutrient function.
• Exhibits technical competence in data analysis and product-related calculations.
• Identify/gain agreement on design criteria, negotiate compromises, balance 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 applicable product regulations and policies.

Supervisory / Management Responsibilities:Exempts Non-ExemptsDirect Reports: 0 0Indirect Reports: 0 0Education:B. S. in Science Related field (Food Science, Chemistry, Microbiology or other technical science areas); Masters degree a plusBackground:

• Displays working knowledge of relationships between regulations, labeling, process, and product.
• Displays working knowledge of applicable product regulations and policies
• Knowledge of FMEA, risk assessment tools
• Knowledge of applicable regulatory standards and requirements for infant formula and nutritional products.
• Knowledge of quality management systems and regulatory requirements.
• Proficient technical writing skills; able to effectively and concisely communicate issues.
• Ability to effectively organize and communicate technical information
• The incumbent must have the ability to work and interact with many cultures in many time zones and be capable of interpreting and analyzing technical data from different regions for decision making.
• Ability to work independently and/or function with minimal supervision.
• Must be able to maintain a high degree of accuracy and analytical thinking.
• Minimum 5 years working experience in the food/nutritional industry and experience in the scale-up and commercialization of product innovations.
• Knowledge of HACCP principles

Accountability / Scope/Budget:This position reports to the Manager, Global Design Assurance. Ensures that all Abbott Nutrition products meet the highest standards for quality required by regulations and is responsible for determining trends in the supply chain and adapting or transforming quality processes to achieve breakthrough improvements. Interruption in the distribution of products can result if these efforts are not well planned and coordinated across the business.,

Keyskills :
javaproject managementdeliverysql servercustomer relationscontinuous improvement facilitationsupply chaindata analysisdesign reviewproject teamswriting skillsstatements of work sowquality management systems