PURPOSE STATEMENT

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.

MAJOR RESPONSIBILITIES

• 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 initiative

EDUCATION

• Bachelors degree in Industrial Engineering, Business Administrator or related career.
• Desirable CQE (CERTIFIED QUALITY ENGINEER certification) given by ASQ.
• B2+ English proficiency.

EXPERIENCE

• Experience of at least 3 years as a quality supervisor/quality engineer in the medical industry.
• 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

At Abb Vie, we are committed to cultivating a workplace culture that promotes inclusion, diversity, and personal growth. We recognize that our collective success is based on the individual well-being of our employees, which is why we have designed a benefits package that considers every aspect of their lives.

• Enhanced Health and Wellness Coverage: Our administrative staff enjoys comprehensive medical and dental insurance, ensuring peace of mind for you and your loved ones.
• Extended Vacation: We believe in the balance between work and personal life for our administrative team. That’s why we offer additional vacation days, beyond legal requirements.
• Flexible Hybrid Work Model: For eligible positions within our administrative staff, we have adopted a hybrid work scheme allowing the convenience of working from home two days a week.
• Life Insurance: Secure your family’s future with our life insurance policy.
• Employee Assistance Program (EAP): Access professional support with our comprehensive EAP, offering psychological, legal, and financial counseling.
• On-Site Health Services: Benefit from the convenience of having a company doctor and physical therapy services, demonstrating our commitment to your health and well-being.
• Community and Social Engagement: Make a difference with a paid volunteer day, allowing you to contribute to the community during company working hours.
• Special Leave Benefits: Celebrate your life achievements with extra leave days for marriage and enjoy your birthday with a day off.
• Employee Stock Purchase Plan: Participate in our company's success by purchasing shares at a special price exclusive to employees.
• Transportation and Meals subsidized.
• Solidary Association: Join a community focused on mutual help and enjoy the benefits that come with being a member.

Abb Vie 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

Abb Vie'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 Abb Vie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.