Quality Assurance Manager North Latam Vascular
hace 3 semanas
**Quality Assurance North LA Manager / Abbott Vascular Division / Medical Devices**
**Mexico City**
**About Abbott**
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
**Working at Abbott**
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:
- Career development with an international company where you can grow the career you dream of.
- A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
**The Opportunity**
As the Quality Assurance North LA Manager, you’ll be responsible of complies with Abbott Vascular Quality Policy. Plans, develops, and manages Quality Assurance organization for Mexico and North Latam Region to ensures the overall compliance and effectiveness of the Quality System for Vascular Commercial Affiliate. Quality Processes: Management Responsibility, Purchasing Controls, Change Management and Document Controls, Product Approval/Marketing Processes, Production and Process Controls (P&PC), Improvement (Corrective Action & Preventive Action-CAPA), Post Market Support Process. Operates under Quality and Regulatory directives and Abbott policies and procedures. Follows local regulations and international industry/ Quality System standards that applies. Provide direction and guidance to team members, evaluate their performance, and assist in career development activities. Ensures that business objectives, budget and quality metrics are met.
**What You’ll Do**:
- Establishes and maintains an effective structure and organization to ensure consistent implementation of the Quality System for Abbott Vascular in Mexico & North Latam Region.
- Being responsible for quality system processes as SME: Supplier Controls and Evaluation, Distributor Management, Market Feedback and Product Experience Reporting, Field and Post-Market Communications, Documentation and Record Control, External Standards and Regulation Compliance, Ad/Promo Document Control, CAPA, Storage and Handling of Finished Vascular Medical Devices, Management Review, Change Control, Customer and Product Training.
- Monitors and ensures compliance with Abbott Policies, Procedures and External Regulations and update Quality System accordingly.
- Oversees Quality System improvements raid implementation projects.
- Drives continuous improvement of core processes to ensure quality is maintained while efficiency is optimized.
- Recommend, implement, and monitor preventative and corrective actions to ensure that quality assurance procedures are achieved.
- Coordinates where required audits by external bodies to the site and ensures where applicable that internal audit schedule is executed in a timely and effective manner.
- Coordinates and implement any audit input to affected processes following change control procedures.
- Ensure Good Documentation and Warehouse Practices
- Responsible for the development and execution for supplier evaluation and monitoring program ensuring that quality materials and services that are used onsite achieve Abbott’s specifications
- Report and conduct follow up for customer complaints and product issues as per established procedures in the affiliate
- Review cGMP regulation applicable to Mexico & North Latam Region to ensuring company processes compliance
- Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives
- Keeps the organization vision and values at the forefront of decision making and action
- Demostraste effective change leadership
- Build strategic partnership to further organizational objectives
- Develops direct reports by securing appropriate training, assigning progressively challenging tasks, and conducting formal written and verbal performance reviews
- Provide support to other functional areas on how to meet QMS requirement in a practical manner
**Required Qualifications**
- Bachelor's degree in Pharmaceutical Chemistry OR Chemical Engineer or 6+ years of related work experience or equivalent combination of education and work experience
- MBA or master’s degree as preference
- Proficiency in advanced English
- Acknowledgement in Quality Assurance roles within Medical Devices industry experience with Mexican and Worldwide Regulation (NOM 241, NOM 240, NOM 137, ISO 13485, ISO 9001, INVIMA, ANVISA, FDA, Health Canada, others) Strong mindfulness and self-motivated
- Minimum experience: 5 years as a Quality Manager.
Follow your career aspirations to Abbott for diverse opportunities with a compan
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