Abbott Vascular Division is looking for a Quality Engineer to develop and maintain quality engineering methodologies and provide quality engineering support within manufacturing, or system/services support to ensure products meet or exceed internal and external requirements.
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).
- ASQ CQE or other certifications preferred.
- Experience working in a broader enterprise/cross-division business model preferred.
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 Engineering or Technical Field.
- 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.
