Abbott is looking to solve quality issues in product development, qualification, and ongoing manufacturing by implementing effective process control systems and robust quality assurance processes.
Requirements
- Demonstrated use of Quality tools/methodologies.
- Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971
- Advanced computer skills, including statistical/data analysis and report writing skills.
- Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
- Working technical knowledge and application of concepts, practices and procedures.
- General understanding of business unit/group function.
- Will perform this job in a quality system environment.
Responsibilities
- Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements
- Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements
- Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
- Design and conduct experiments for process optimization and/or improvement
- Appropriately document experiment plans and results, including protocol writing and reports
- Lead process control and monitoring of CTQ parameters and specifications
Other
- Bachelors Degree in Engineering or Technical Field or equivalent experience or an equivalent combination of education and work experience
- 0-2 years Engineering experience
- Solid communication and interpersonal skills.
- Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
- Ability to work in a highly matrixed and geographically diverse business environment.
