Abbott is seeking a Supplier Development Quality Engineer Lead to implement and maintain an effective Quality System, ensuring compliance with FDA, ISO 13485, and internal quality standards, and driving supplier performance improvements.
Requirements
- Knowledge of applicable US and non-US Quality System Requirements and other relevant regulations for medical devices.
- Previous experience with regulatory body. Knowledge of software regulations and compliance (21 CFR Part 11); -
- Knowledge of medical device standards, ISO 13485.
- Knowledge of quality management techniques and the application and principles of quality engineering.
- Strong knowledge and application of concepts, practices and procedures.
- Understanding of statistics.
- Ability or aptitude to use various types of databases and other computer software.
Responsibilities
- Work cross-functionally to lead Quality System process improvements which may include training, corrective action and preventive action (CAPA) activities, product and process planning, quality audits, and qualifications.
- Provide training and mentorship to internal stakeholders on supplier audit processes and compliance expectations.
- Independently lead cross-functional teams to analyze and resolve complex issues with broad operational impact.
- Draw conclusions reflecting broad business needs. ensure compliance.
- Responsible for completing documentation in a timely manner and in accordance with business standards.
- Understand and comply with applicable EHS policies, procedures and guidelines.
- Work may require collaboration with other Division sites and/or other Abbott divisions.
Other
- Bachelors Degree Preferably in science, engineering or a closely related discipline or an equivalent combination of education and work experience
- 5 years of relevant experience
- Ability to form and develop interpersonal, professional relationships; display socially and professionally appropriate behavior.
- Ability to work independently and in groups; ability to work cross-functionally.
- Ability to travel approximately 40% annually
