A SENIOR QUALITY MANAGER is required by CareerWise Recruitment for our client in Clare for a full time, permanent position.
The SENIOR QUALITY MANAGER will lead the quality team, supporting the design and manufacture of a range of devices within a customer-facing medical device contract design and manufacturing organization.
THE ROLE:
* Day to day management of quality function.
* Leads Customer facing quality discussions and implementation of quality plans for new customers and new projects.
* Guides internal team on industry best practices.
* Plan and grow quality team and function to meet future requirements in a growing organization.
* Monitor and manage CAPAs and customer complaints, taking ownership for the development, documentation and implementation of corrective actions
* Lead the classification and investigation of non-conformances, and assignment of root cause determinations and drive for timely resolutions
* Interfaces directly with Notified Bodies, and other regulatory agencies on matters pertaining to processes, products or Quality systems compliance.
REQUIREMENTS:
* Bachelor’s degree in Science, Engineering, Quality Management or related fields. Master’s degree is preferred.
* Minimum of 10 years of experience in Medical Device industry.
* Experience working with Electromechanical based Class 2 medical devices an advantage.
* Experience and working knowledge of cleanroom and non-clean room manufacturing an advantage.
* Working knowledge of regulations and standards (e.g., 21CFR210, ISO 13485, MDD, MDR, etc.) with experience in executing Quality strategies.
Please call Tom Devaney today for further information on 091-758771 or email: tdevaney@careerwise.ie
CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.
We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.
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