Quality Engineer – Co. Cork
Role Summary:
- A fantastic opportunity has arisen for a Quality Engineer to join our client’s facility in Co. Cork.
- The successful candidate will provide effective and responsive QA support to Operations to resolve in-house, customer and supplier issues.
- The Quality Engineer will ensure Regulatory compliance in the area of responsibility to GMP of all medical devices regulatory agencies (i.e. FDA, IMB and BSI).
Core Duties and Responsibilities:
- Assist in development, review and approval of process and equipment validation (IQ, OQ and PQ).
- Ensure compliance of QMS procedures within the Business Unit.
- Lead Problem Solving meetings using the following: 4D, Six Sigma, etc.
- Lead pFMEA/Dynamic Control Plan (DCP) activity and ensure that all failure modes in process have been identified and addressed.
- Drive and implement plant wide quality system improvements.
- Participate in the development and improvement of the manufacturing processes for existing and new products. Coordination of PPAP activities.
- Provide functional expertise to other support function on quality related issues.
- Manage NCR Process.
- Interface with Suppliers for new processes, quality Issues and Process Improvements.
- Work cross functionally with such groups as Regulatory, Product Development and Operations to ensure all issues are successfully resolved.
- Lead training activities on Quality related Procedures, e.g. Compliance, GMP, Audit Prep and GDP.
- Support Manufacturing Cell in addressing Quality Metrics, e.g. CAPA, sCAPA, Validations, Process Changes, NCR, Quality Alert, Quality Challenge.
- Complete Manufacturing Cell Audits, Internal Audits Supplier Audits, as required.
- Support site during External Audits. (i.e. FDA, IMB and BSI).
- Support/ act as local subject expert for review, creation and training of divisional/corporate procedures.
- Responsible for input to Quality Metrics.
- Evaluation of Customer Complaints (PER Investigation) as required.
Minimum Qualifications and Experience:
- Degree in Engineering, Science or equivalent is required.
- 0 – 2 years experience in a QA role.
- Good level of technical and analytical skills.
- Problem Solving Skills and ability to handle multiple tasks in a fast paced environment.
- Capable of working as part of a multi discipline team.
- The individual should enjoy working in an aggressive, dynamic and results motivated team environment.
- High level of PC skills required.
- Excellent Communicator
To Apply: Quote – PE23094
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
14 Danville Business Park, Kilkenny, Ireland
+353 56 77 90100
[email protected]
Please note, we do not require agency assistance with this role.
