Title: Senior Manufacturing Quality Engineer
Benefits: Opportunity for career progression, salary, pension, healthcare and yearly bonus.
My client are a Medical Device multinational who manufactures and markets products that simplify, automate and innovate complex biomedical tests.
- Co-ordinate the Manufacturing Non-conformance process (NC) for all Production areas ensuring compliance to Quality and Regulatory Standards.
- Lead cross functional teams providing Quality guidance and support.
- Responsible for the Rework process, ensuring relevant documentation is prepared.
- Execute the Stop Ship process for finished product released to the market
- Responsible for ensuring the Manufacturing Quality Procedures are current and in line with global procedures
- Initiate/review/approve document Change Controls (CCFs) and Equipment Change Controls (ECCs)
- Ensure quality issues are communicated to the management team such that they are aware of any potential problems or opportunities
- Review/approve Validation documentation (e.g. protocols, reports) ensuring compliance to applicable procedures.
- Generate, update, implement and complete associated training for relevant departmental procedures, as required.
- Assist in the Supplier Quality process acting as a Supplier Quality representative, if applicable
- Assist with the QA review & disposition of Batch History Records (BHRs) for all product lines and complete the associated ERP activities ensuring relevant logs and BHRs are maintained.
- Perform CAPA (corrective and preventive action) activities and document in the Global CAPA system if required.
- Bachelor' s degree in chemistry, biochemistry, engineering or other relevant technical field with a minimum of 3 years' experience in a highly regulated industry.
- Desirable to have previous experience in IVDDs and Manufacturing Quality.
- Good knowledge of ISO9001/ISO13485, FDA and GMP requirements.
- Excellent time management, planning and organisation skills.
- Must have a working visa for Ireland
If you are interested in applying or hearing more about this opportunity and others like it, forward a copy of your update CV.
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales