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 improvements to quality and manufacturing processes, aiming to resolve defects in a timely and efficient manner. MAJOR RESPONSIBILITIES: Evaluate, propose, and implement medium complexity improvements in process quality, guided by the area manager, to strengthen processes and enhance efficiency. Seek solutions for problems identified in manufacturing and process quality areas using Lean tools. Support assigned root cause investigations (NCRs), develop action plans, and implement corresponding actions within the established timeframe. 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, and propose changes to PFMEAs for projects where assigned as a Quality representative. Review OT Core System documents and validation/qualification protocols (IQ, PPQ, IOQ, IO, PR, etc.) when assigned as a quality representative for complex systems. Support key company projects, including defining and implementing controls aimed at ensuring product quality. Ensure the order and cleanliness of the responsible areas (5S) and comply with quality goals within the corresponding period. Perform other functions inherent to the position and those assigned by the immediate manager. Comply with corporate and legal EHS requirements, adhering to internal policies and procedures; ensure compliance through strategies, internal controls, communication, and training. Continuously maintain EHS results through leadership, commitment, and participation in all EHS-related initiatives.
EDUCATION: Bachelor’s degree in Engineering, Business Administration, or a related field. CQE (Certified Quality Engineer) certificate by ASQ is desirable. B2+ English proficiency. EXPERIENCE: Minimum 3 years of experience as a quality supervisor/engineer in the medical industry. (Desirable)Experience in product transfer, quality systems, validations and manufacturing, new procedural definition, and risk assessment documentation. SKILLS: Data-driven decision making and risk management Intermediate statistical knowledge Project management Critical thinking Focus on excellence Open and authentic Communication
At AbbVie, 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. 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