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NPI Quality Manager
Exciting contract opportunity for a NPI Quality Manager in a manufacturing in South Dublin. Our client is a well-known high volume manufacturing company, leading healthcare safety and technologies for more than a century.
Reporting to the Senior Quality Manager, the NPI Quality Manager holds a pivotal role in leading new product introduction activities and serves as the primary contact for key customers. Responsibilities includes project management, overseeing and approving process validation studies, implementing Statistical Process Control (SPC) in current production processes, and fostering partnerships with essential stakeholders.
– Providing comprehensive support for ISO9000/ISO13485 Quality Systems.
– Ensuring compliance with all internal, external, and pertinent regulatory standards.
– Integrating as a crucial member of the Dun Laoghaire Quality Leadership Team.
– Direct day-to-day leadership and management of the NPI Quality Engineering Team, overseeing their development through engagement, delegation, and regular performance assessments according to established goals.
– Drafting and maintaining documentation in accordance with relevant regulatory prerequisites.
– Supporting significant improvements in manufacturing concerning product quality.
– Overseeing GMP compliance in Production and Quality Engineering activities.
– Facilitating and executing validation activities successfully in collaboration with the site validation team to meet NPI program timelines.
– Supervising essential elements of quality systems directly linked to production support, such as the non-conformance system, incident reporting system, and analysis of customer complaints. Managing the Quality control group and their operations.
– Engaging with key external customers to address concerns and ensure satisfaction.
– Ensuring all corrective and preventive actions (CAPAs) under your supervision comply with regulatory and procedural obligations.
– Bachelor’s degree in Engineering or Science Discipline.
– 5 years + of work experience in ISO 9001/2000 or ISO 13485 environments, along with a background in the Medical Devices/Pharmaceutical Industry.
– Experience in Technical Documentation preparation.
– 3 years + of supervisory experience.
– Proficiency in Statistical Process Control and familiarity with Six Sigma methodologies (Greenbelt Certification would be advantageous).
– Expertise in CAPA system management.
– Background in process validation, Sterilization, and clean room environments would be advantageous.
– Working knowledge of FDA requirements and experience in managing FDA audits.