Job Description
Senior Quality Manager sought for a full-time, permanent position in Clare, leading the quality team in a customer-facing medical device contract design and manufacturing organization.
The successful candidate will be responsible for managing the quality function, leading customer-facing quality discussions, and implementing quality plans for new customers and projects.
Key Responsibilities:
- 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
- Plans and grows quality team and function to meet future requirements in a growing organization
- Monitors and manages CAPAs and customer complaints, taking ownership for the development, documentation, and implementation of corrective actions
- Leads the classification and investigation of non-conformances, and assignment of root cause determinations and drives 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
- Masters degree 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., 21 CFR210, ISO 13485, MDD, MDR, etc.) with experience in executing Quality strategies
Career Wise Recruitment is a specialist recruitment agency established in 1999, providing career opportunities in the life sciences, ICT, engineering, food, and agri sectors.
We operate out of multiple locations in Ireland and have offices in various locations.
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