- Reference: CJ43012y
- Job Type: Permanent
- Location: Cork, Cork city, Munster
- Category: Production
Key Areas of Responsibility:
The Quality Engineer- Operations support will be the primary contact between Quality Assurance and Operations. This person will provide expert QA support to Operations, in ensuring plants and business unit goals and objectives are achieved.
- Provide effective and responsive QA support to Operations to resolve in-house quality issues, and support the resolution of Customer and Supplier issues as required.
- Drive and implement plant wide quality system improvements.
- Work cross functionally with such groups as Regulatory, Product Development and Operations to ensure all issues are successfully resolved.
- Support/ act as local subject expert for review, creation and training of divisional/corporate procedures.
- Support Manufacturing Cell in addressing Quality Metrics, e.g. CAPA, Validations, NCR,Quality Awareness Tests.
- Responsible for input to Quality Metrics
- Participate in the development and improvement of the manufacturing processes for existing and new products.
- Provide functional expertise to other support function on quality related issues.
- Lead training activities on Quality related Procedures, e.g. Compliance, GMP, Audit Prep and GDP.
- Has the authority to order the cessation of production and product shipments in the event of a non-conformance arising. Also has the authority to order the recommencement of production provided he/she is satisfied that all issues pertaining to the non-conformance have been addressed.
- Coordination of MRB activities to the business unit to ensure the timely assessment of potential non-conforming products.
- Support pFMEA/Dynamic Control Plan (DCP) activity and ensure that all failure modes in process have been identified and addressed.
- Evaluation of Customer Complaints (PER Investigation) as required.
- Problem solving / Trouble shooting of customer complaint investigations, coordination of root cause and risk assessments.
- Lead risk assessment activities and ensure that all failure modes in process have been identified and addressed.
- Lead Problem Solving meetings using the following: 4D, DMAIC etc.
- Assist in development, review and approval of process and equipment validation (IQ, OQ and PQ).
- QA review and approval of unplanned maintenance routines.
• Support site during External Audits. (i.e. FDA, IMB and BSI) and Internal Audits as required.
- Ensure Regulatory compliance in area of responsibility to GMP of all medical devices regulatory agencies (i.e. FDA, IMB, BSI etc).
- Ensure compliance of QMS procedures within the Business Unit.
For a confidential discussion and more information on the role, please contact Rory on 021 4911063 or email email@example.com
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