Abbott Vascular needs a Quality Engineer to perform quality engineering activities, develop and maintain data integrity and cybersecurity policy, and work with cross-functional teams to identify and mitigate risks, ensuring compliance with regulatory requirements and best industry practices.
Requirements
- Strong technical knowledge and application of concepts, practices and procedures.
- Ability or aptitude to work on problems that are complex in scope where analysis of situations or data involves multiple competing factors.
- Ability and aptitude to use various types of databases and other computer software.
- Demonstrated competency with financial systems and in fiscal controls.
- Responsible for implementing the effectiveness and maintaining compliance of the Quality System. (e.g. compliance with internal procedures and FDA, BSI regulations etc).
- Responsible for completing documentation in a timely manner and in accordance with business standards.
- Serve as a subject matter expert (SME) on a subset or select subsets of a project's technical matters.
Responsibilities
- Perform Abbott Vascular quality engineering activities by developing and maintaining data integrity and cybersecurity policy, standards, applications, systems, etc.
- Work closely with R&D, Equipment Engineering, Quality Engineering and IT on risk identification and mitigation activities.
- Facilitate cross functional team collaboration to achieve data management goals.
- Support project planning and perform assessments and mitigations with cross functional teams.
- Provide support to internal and external audits.
- Manage relevant audit findings and CAPAs.
- Continuously improve processes to align with current and emerging regulatory and customer requirements and best industry practices.
Other
- THIS POSITION IS ON-SITE DAILY REQUIRED.
- NO RELOCATION ASSISTANCE IS AVAILABLE FOR THIS POSITION.
- Ability to form and develop interpersonal, professional relationships.
- Display socially and professionally appropriate behavior.
- Ability to work independently and in groups.
