Abbott is looking to solve quality engineering challenges within new product development, manufacturing, and system/services support for their Electrophysiology (EP) division, aiming 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.
- Prior medical device experience 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.
- 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.
- Lead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
Other
- Lead, coach, and mentor non-exempt and lower-level exempt personnel.
- Strong 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.
- Ability to work within a team and as both a leader and individual contributor in a fast-paced, changing environment.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
