Quality Senior Engineer
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Heredia, Heredia Province
- Operations
- On-Site
- Full-time
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Ensure that our product is functional and safe for the end customer by understanding, developing and
applying quality control systems, as well as analyzing, proposing and implementing improvement of
quality and manufacturing processes, thinking about improving defects in a timely and efficient manner
- Evaluate, propose and implement high complexity improvements in processes in the process
quality area, seeking to strengthen processes while improving their efficiency, guided and advised
by the area manager . - Search for solutions to problems identified in the areas of manufacturing and process quality
through the application of Lean tools. - Support assigned root cause investigations (NCRs), as well as the development of action plans and
the implementation of corresponding actions, during the established period of time. Review and
Approve documents for High Impact NCR. - Develop and establish new processes and procedures from a quality perspective based on the Risk system evaluation, be part of the process and product transfer projects from the planning stage to its operationalization with high understanding of the ISO standard and other regulations.
- Coach and train colleagues to achieve a high performance team following the department's
purpose, as well as make high-impact decisions evaluating the risk in the absence of the manager - Review and approve quality plans and First Article Plans related to the production process with low to high complexity, as well as propose changes to PFMEAs, this for those projects where you are assigned as a Quality representative.
- Perform reviews to OT Core System documents as well as validation/qualification protocols (IQ,
PPQ, IOQ, IO, PR, etc.) where assigned as a quality representative complex and advance system. - Provide support to key company projects, including definition and implementation of controls
aimed at ensuring product quality. - Ensure the order and cleanliness of the areas under your responsibility. (5's) and comply with
quality GO's in the corresponding period. - Do the other functions inherent to the position and those assigned by your immediate manager.
- Meet compliance with corporate and legal EHS requirements, by complying with internal policy and procedures. In addition, ensure compliance through the adoption of necessary strategies, internal controls, communication and training.
- Continuously maintain EHS results through leadership, commitment and participation in all EHS-related initiatives.
Education:
- Bachelors degree in Industrial Engineering Bussiness Administrator or related career.
- Desirable CQE (CERTIFIED QUALITY ENGINEER certification) given by ASQ.
- Intermediate/advanced English proficiency.
Experience:
- Experience of at least 3-5 years as a quality
supervisor/quality engineer in the medical
industry. - Plus: Experience in product transfer, quality
system, validations and manufacturing, new
procedure definition, risk assessment
documentation development.
Skills:
- Critical thinking
- Focus on excellence
- Open and authentic
- Project management
- Communication
- Decision based on data analysis and Risk
approach - Advance Statistical Knowledge
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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
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Where We Work
Role is exclusively performed at a site or office and onsite presence is required. Employees who are site/office-based and can occasionally perform their role virtually work both in the office and remotely*, following the policies and regulations in place at their location. US Employees must be in the office on Tuesday, Wednesday, and Thursday with flexibility to work remotely on Mondays and Fridays. Three days in the office is the minimum; some individuals or teams may require more in-office days due to meetings, business/project needs or their role.