Engineer, Quality Assurance CAPA III

PURPOSE STATEMENT
Manage the resolution of exception reports linked to the Quality System (NCRs PRAs) and audits providing support in the review and approval of the relevant documentation for the processes mentioned including problem definitions investigations audit responses action implementation and others. Ensure compliance with standards (GMPs) and the safety quality and finance regulations defined by the company.

MAJOR RESPONSIBILITIES

1. Review and approve documents derived from exception reports related to the Quality System in order to document the outcome of the investigation process including containment correction and prevention actions that address the root cause of the finding as well as the mechanism to verify the effectiveness of the actions implemented.
2. Act as SME in working sessions for quality system events with experts from the areas involved in the finding in order to develop the investigation and define containment correction and prevention actions.
3. Guide the NCR or audit process to ensure that the documentation prepared meets internal and regulatory requirements.
4. Manage and prioritize the available resources for the execution of containment correction prevention and effectiveness verification actions arising from exception reports in order to ensure timely completion in accordance with the quality system metrics: status updates extensions implementation reports among others.
5. Explain as a Quality SME the exception documents requested during external or internal audit processes.
6. Ensure timely compliance with NCR commitments in order to support site quality metric performance.
7. Continuously improve processes and documentation related to the Quality System through process simplification and optimization.
8. Ensure compliance with corporate and legal EHS requirements by adhering to policy and internal procedures. Likewise ensure compliance through the adoption of strategies internal controls communication and necessary training.
9. Continuously improve EHS results through leadership commitment and participation in all EHS-related initiatives.
10. Perform all other duties inherent to the position and those assigned by the immediate supervisor.

Qualifications :

• Bachelors degree in Engineering Preferred:  Electromechanical Engineering Electrical Engineering or Chemistry.
• Intermediate English B2 (C1 preferred).
• At least 3 years of experience leading the resolution of CAPAs and NCRs as well as internal and external audit observations and regulatory agency findings related to the Quality System.
• At least 1 year of experience in a quality system tied to ISO 13485 medical device regulations.
• At least 3 years of experience in manufacturing processes in the medical industry.
• Preferred: ISO 13485 Lead Auditor.
• Data and Statistical Analytics.

Additional Information :

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time