Quality Assurance Engineer (Vacantes Temporales y Permanentes) - job 2 of 2
Company Description
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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description
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 medium 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 Medium Impact NCR.
- Review and approve quality plans and First Article Plans related to the production process with low to medium 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 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
Qualifications
- Bachelors degree in Industrial Engineering, Bussiness Administrator or related career.
- Desirable CQE (CERTIFIED QUALITY ENGINEER certification) given by ASQ.
- Intermediate English level, able to hold conversations and present issues related to the industry, and able to draft technical documents, such as procedures and specifications.
- Experience of at least 2 years in the quality department in medical industry or demostrable experience for position.
- Plus: Experience in product transfer, quality system, validations and manufacturing, new procedure definition, risk assessment documentation development.
- Decision based on data analysis and Risk approach
- Intermediate Statistical Knowledge
- Office (Word, Excel, Power Point, Visio), SAP, and Minitab.
- Problem solving using a Lean tool, such as PDCA, A3, DMAIC, Value Stream Mapping, or others.
- Visual acuity: Normal 20/20 vision (if necessary with prescription lenses) is required for the position.
- FDA, QSR and ISO13485
Additional Information
We offer:
- Chance to become a part of dynamically growing biopharmaceutical company.
- Friendly organizational culture.
- Hybrid working model (3 days in the office, 2 days from home).
- Training opportunities and professional development.
- Flexible working hours and additional days off (Abbvie Days).
- Charity initiatives incl. Week of possibilities - days of employee volunteering.
- Extensive benefits package (Multisport, private medical care, life insurance).
- Wellness initiatives – global events promoting work-life balance, physical and mental well-being
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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AbbVie’s mission is to discover and deliver innovative medicines 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: i...
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