Quality and Compliance Manager
hace 2 semanas
_MAIN PURPOSE OF ROLE_
This position provides leadership and guidance for the Quality Assurance and Compliance supporting function at Abbott Vascular Costa Rica.
Responsible for developing functional goals objectives, procedures, policies, and systems that are in line with the company objectives, quality policy, regulatory standards, and applicable regulations.
This role will also drive quality and compliance culture and educational programs, key performance metrics, and procedures to ensure quality system compliance, site audit readiness, batch release, receiving inspection and Corrective Action and Preventive Action (CAPA) effectiveness for the site.
_ MAIN RESPONSIBILITIES_
- Does the job have direct reports_? _Yes
- Does the job have indirect reports?_ Yes
- Recruit, coach, reward, and develop diverse organizational talent.
- Foster a diverse workplace that empowers others to perform at their best by driving continuous improvement.
- Set strategy that translates into actionable, aligned team goals.
- Take initiative, gather data, and develop scenarios plans commensurate with risk.
- Provides direction and guidance to exempt specialists and/or supervisory staff. May supervise nonexempt employees.
- Keeps the organization's vision and values at the forefront of decision making and action.
- Demonstrates effective change leadership through continuous observation and aligns systems to drive ideal behaviors at all levels of the organization.
- Builds strategic partnerships to further departmental and organizational objectives.
- Develops and executes organizational and operational procedures and policies that affect one or more groups by utilizing technical/professional knowledge and skills.
- Monitors compliance with company policies and procedures (e.g. compliance with FDA, EUMOR, ISO regulations, etc.).
- Manage administrative tasks related to overall resource management of the area under responsibility in collaboration with management.
- Responsible for coordination, facilitation and tracking of site management review meetings, quality data reviews and other operational quality reviews, preventive actions, and provide inputs on the Quality Management System effectiveness.
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
This position works out of our
Costa Rica location in our Vascular division.
Our business purpose is to manufacture devices designed to optimize angioplasty procedures, including stents, diagnostic and imaging devices, catheters, guidewires, and vessel-closure devices.
As the
Quality and Compliance Manager position, you will be responsible for managing activities and areas that support the shared Quality Services within Abbott Vascular Costa Rica to ensure quality compliance, external audit readiness, risk management, batch release, and receiving inspection and CAPA program activities are executed and tracked by Abbott Quality System requirements and applicable regulations.
Also, will provide leadership and guidance for the Quality Assurance and Compliance team and responsible for developing goals, objectives, procedures, policies, and systems that are in line with company goals and objectives, mission and vision, and standards and applicable regulations.
What You'll
Work On
- Responsible for coordination, facilitation, and tracking of site management review meetings, quality data reviews and other operational quality reviews, preventive actions, and providing inputs on the Quality Management System effectiveness.
- Monitors compliance with company policies and procedures (e.g., compliance with FDA, EUMOR, ISO regulations, etc.).
- Maintain and implement necessary improvements to ensure site audit readiness for audits. Periodically evaluate and escalate compliance risks and coordinate remediation activities to ensure compliance with applicable requirements.
- Keeps the organization's vision and values at the forefront of decisionmaking and action.
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