Exciting new opportunity for a Quality Compliance Lead with an excellent company in County Clare on a permanent basis.
The primary responsibility of the successful candidate is to lead the Quality Compliance function to assure conformance to established requirements and standards for products and processes through the effective implementation of the Quality Management System processes.
This will entail directing and/or supporting the Quality Management System processes, including but not limited to Corrective and Preventive Action, Internal and External Audits, Quality Trending, Quality Management Review and document and record control.
* Manages the Quality compliance function and provides leadership and direction to the Quality Compliance team.
*Oversees effective implementation of the Quality Management System (QMS) throughout the organization, including leading gap assessment and closure for any regulatory changes that have impact on the quality management system and actively coaching the organization to support the effective implementation and maintenance of a QMS.
* Supporting Top Management in the development and implementation of quality systems strategies and objectives.
* Maintains the site Quality Manual and Quality Systems Procedures and ensure contents are aligned to the Global regulations/standards.
* Manage and monitor quality trending process for determining the effectiveness of applicable quality systems, develop processes and plans to address improvements as identified.
* Leads site internal audit program, including conducting internal audits and ensuring that audits are completed on time and in full and that all observations are being addressed by owners as appropriate.
* Coordinates and supports effective management review process, ensuring all key quality performance trends are identified and dispositioned.
* Manages any 3rd party external audits and corporate audits through preparing the site; including managing the back room and supporting the front room.
* Manages the document control function to ensure all relevant QMS documentation is accessible and up to date following site change management process.
* Bachelor's degree in engineering or an alternative Bachelor's degree with certification as a Quality Engineer (e.g. CQE)
* 5 years' experience in a Quality Engineering role of similar position required.
* Experience working in a highly regulated industry, preferably medical devices or pharma.
* Strong compliance specialist with experience in audits, external audits, CAPAs, non- product related quality.
* Experience managing a small team of 3 Quality Specialists highly desirable.
Please call Michelle Galvin today for further information on 091 373 938 or email: email@example.com
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.