Quality Manager - Queretaro site in Mexico
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.Main Purpose Of the Role This position is responsible for developing, establishing and maintaining quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency regulations. This individual develops and executes the required strategies and plans to improve product and process quality in order to deliver planned business results and assure compliance with FDA and ISO regulations and any country specific regulation were product is distributed. This position is responsible for collecting and documenting management review information, conducting regular meetings, and reporting the information to the plant's leadership team and the appropriate Divisional Management Representative. Main Responsibilities • Management and development of applicable Quality department personnel.
• Provide Quality Engineering Body of Knowledge guidance and leadership to department and organization.
• Aggressively identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.
• Aggressively identify and manage activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility.
• Define and implement superior Process Control & Monitoring systems for critical process indicators throughout the product lines – Critical Parameter Management.
• Identify Quality Initiatives and lead cross-functional teams to complete them.
• Provide proactive, diligent, and fact-based communication to Sr. Management team, peers and team.
• Assess resource needs to assure that the accurate level of quality support is provided when needed with the competencies needed.
• Oversee the facility's implementation of and compliance with Non conformance and CAPA systems.
• Be an effective member of the cross-departmental Functional Management Team to foster continuous quality compliance, cost, and proactive improvements.
• Maintain effective Quality Metrics and define and execute activities to resolve decreases in performance.
• Be a champion of Quality, Six Sigma, Lean, Opex and disciplined problem solving throughout the organization.
• Prepare the department budget and salary plan revisions.
• Verify adherence of New Product Introductions to the established Quality System, international standards and agency regulations.
• Prepare the department objectives for the fiscal year. This includes project plans, training, development, and other specific work plans.
Qualifications Education Education Level: Bachelor's degree (4-year degree) Major/Field of Study: Engineering, Science or Technical Field, or Bachelor's degree in Business Administration. Experience/Background Experience: 7 years of experience in a regulated industry, with 5 years in Quality roles.
Experience Details :
Demonstrated extensive experience with Domestic and International regulatory requirements and regulating bodies required.FDA Class II or Class III medical device experienceSolid knowledge of and experience working with international quality regulations, including US 21 CFR 820 (QSR) and ISO 13485.Demonstrated and impactful experience with product and process qualification and validation, process improvement, lean and six sigma methodologies, process control and monitoring (SPC).Demonstrated results in nonconformance management and reduction, value improvement, risk reduction and cost containment.Demonstrated organizational influence to include, but not limited to: compliance excellence, organizational improvement, product-related risk mitigation, and/or manufacturing cost reduction & Opex.Ability to travel to support domestic and international manufacturing sites (up to 15%).Preferred Qualifications & Education: Master´s degree.5+ years in Quality with roles of increasing responsibility, impact, and scope within a manufacturing support environment.FDA Class II or Class III medical device experience.Quality or Lean Certifications (i.e. Six Sigma Belt, ASQ CQE/CRE/CQM).Opex & Project ManagementLanguage Proficiency - Excellent English / Required Apply Now Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
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