Abbott is seeking a Manager in Quality Engineering to lead and develop an engineering team responsible for operations quality, design changes, transfer projects, and post-market surveillance within assigned product areas in the Neuromodulation Division.
Requirements
- 4-year degree; industry certification or advanced degree, electrical or mechanical engineering preferred.
- Class III or II medical device experience (catheter experience preferred).
- Deep understanding of risk management in design, manufacturing and post-market surveillance.
- Demonstrated and impactful experience in process improvement (KPIV, KPOV, Fishbone, Is/Is Not, QFD), Six Sigma, product and process qualification and validation, Process Control & Monitoring (SPC).
- Lean Six Sigma Black Belt strongly preferred.
- ASQ Certified Quality Engineer strongly preferred (CQE, CRE).
- Experience working in a broader enterprise/cross division business unit model preferred
Responsibilities
- Provide leadership in direct support of medical device manufacturing.
- Management and development of Quality Engineers and Technicians.
- Own the activities of the Post-Production Quality Engineering team.
- Ensure successful planning, management and execution of area projects.
- Provide Quality Engineering Body of Knowledge guidance and leadership to department and organization.
- Define and implement Process Control & Monitoring systems for KPIV and KPOV throughout the product lines – Critical Parameter Management.
- Approve/author experimental plans, protocols and reports, including supporting teams on appropriate statistical analysis techniques.
Other
- 5+ years in quality desired with roles of increasing responsibility, impact, and scope within a manufacturing support environment.
- Strong project management and people leadership skills required.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Strong leadership skills, including the ability to set goals and provide positive and constructive feedback to build positive relationships and improve business results.
- Ability to travel approximately 5-10%, including internationally
