About AbbottAbbott 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: Opportunities to grow and achieve your career aspirations within an international company.Benefits Package: Excellent pension and family healthcare benefits.Recognition: The company is recognized globally as a great place to work and has been named one of the most admired companies by Fortune.Diversity and Inclusion: Known for being one of the best big companies to work for, especially for diversity, working mothers, female executives, and scientists.MAIN PURPOSE OF ROLE The Associate Director supports and coordinates the Quality Assurance activities for the Division Manufacturing Plants and Third Party Manufacturing (TPM) facilities globally.Designing and implementing quality assurance systemsto ensure high product quality and customer satisfaction.Advising senior leadershipon critical issues related to product quality, safety, and regulatory compliance.Leading complex global investigationsto address quality and safety concerns.Coordinating strategies and activitieswith various leadership teams across Global Operations, Engineering, R&D, Commercial Operations, Regulatory Affairs, and Legal.Interfacing with external business partners and regulatorsto maintain compliance and address any issues.Additional ResponsibilitiesDevelop quality strategies to achieve business objectives across the division manufacturing plants and TPM's ensuring alignment in processes/systems where possible.
Lead the quality assurance processes across different regions and product lines, ensuring that products meet quality standards and regulatory requirements.
Provide oversight to disposition of high-risk product nonconformance situation, assure adequate technical investigations and appropriate corrective actions are in place to prevent reoccurrence.
Support the resolution of product quality issues resolutions to on market products.
Responsible for supporting the implementation of multi-million-dollar capital projects at the Division Manufacturing Plants and Third-Party Manufacturers globally.
Provide leadership and direction to Manufacturing QA & TPM teams (Technical, Operations and Engineering) to enhance and improve regulatory compliance while meeting customer requirements.
Act as key technical Quality interface between TPM's and ADC internal departments including Ops, Engineering, R&D, RA, Technical and commercial.
Manage multiple complex projects in parallel across multiple locations with cross functional, cross company teams.
Assure successful launch of new and revised products by incorporating the appropriate quality assurance programs / systems into site operations to meet goals for division.
Identify and delivery CI Projects to a value of at least $1MM annually.
Analyze quality metrics and performance data to identify trends, generate insights, and report findings to senior leadership, facilitating informed decision-making.
Oversee and mentor quality engineering teams, fostering a culture of continuous improvement, collaboration, and professional development.
Control Budget and quality cost across the network as required.
Develop Community of Practices within ADC division / TPM network utilizing industry contacts to develop best practice approaches.
Apply lean sigma methodology during problem solving activities.
Support manufacturing and TPM's sites during regulatory inspections.
Education and Years Experience:Third level qualification in Engineering, Quality, or Science (Engineering qualifications most advantageous)7 years' experience in manufacturing environment including 5 at leadership level