|Sector||:||Manufacturing & Production|
|Tel||:||094 900 3979|
Role of this position
- Act as the Manufacturing Lead with respect to the thorough investigation of Non-Conforming Materials and Complaints, using Data Analysis/Problem Solving Techniques to arrive at Root Cause and identify Corrective & Preventative Actions to prevent recurrence.
- Provide regulatory support for new product and support to Operations, Sterilisation and Labelling/Packaging.
- Review and update of Regulatory documentation to ensure compliance with current ISO standards, relevant FDA guidelines and EU Directives
- Process Audits of the manufacturing lines to ensure the product being manufactured complies with all requirements, and that the Equipment/Process in use complies with the relevant Standard Operating Procedures.
- Identify and suggest improvements to current equipment, processes, and procedures to streamline the manufacturing activities while ensuring high standards of quality.
- In conjunction with the Manufacturing Engineer, provide advice and support to processes that require investigation or development with the goal to improve and make robust.
- Be an active Team Member on Continuous Improvement Projects by delivering on actions committed to, critiquing current methods, and suggesting alternatives/improvements.
- Support the Manufacturing Engineer and cross functional teams on the collation of data and the resolution of processing issues.
- Actively promote Quality within the Manufacturing group, and assist the Quality Department on introducing initiatives into the Manufacturing Department
- Lead Manufacturing Driven initiatives with respect to quality within the department
- Batch Record/Lot History Review to ensure Product Compliance/GMP/GDP are as per relevant procedures prior to final QA Release.
- The Manufacturing/Regulatory Quality Engineer will have a primary degree or equivalent in Engineering/Science discipline.
- Medical device manufacturing experience is essential, 4 plus years.
- Hands on experience in Medical device manufacturing are essential.
- Must have a good working knowledge of production and quality system requirements in the health care industry (13485:2003 and FDA QSR Parts 820)
- A Green or Black Belt in Lean Six Sigma would be a distinct advantage
Please call Louise Mulligan today for further information on 094 900 3979 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 Medical Devices, Pharmaceuticals, 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.