Quality Engineer

Dublin South  ‐ Onsite
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Description

I have an immediate opening for a Quality Engineer with a leading medical device company based in Dublin. This role is on shift pattern comprising of 2 x 12 hour shifts - 2 x day and 2 x night (Very competitive salary with shift premium).

Job Purpose:
* Reporting to the Quality Engineering Manager, duties will include active participation in non-conformance investigations and lot disposition decisions, application of SPC to current production processes and liaison with key customers. The role also involves the supervision of QA/QC laboratories, approving of process validation studies, management of justified complaints investigations, and participation in change control processes and in process related adjustments and leading or participating in process improvement projects.

Responsibilities:
* Managing the activities of the Quality Inspectors to ensure optimal efficiency and compliance with all regulatory requirements.
* Drive root cause analysis of non-conformances with relevant personnel and ensure corrections are implemented before starting back to production after a quality issue.
* Drive and maintain cGMP practices across all operational departments under your quality responsibility (Incoming, moulding, assembly, packaging sterilization, warehouse) and attend departmental and other meetings as appropriate.
* Preparation of relevant work sheets and execution of final inspection tests and line clearance verification.
* Release batches in SAP from packaging to sterilization and final release.
* Complete DHR reviews and batch releases.
* Provide GMP guidance in case of rework and/or inspection protocols.
* Line clearance verification.
* Complete Product Quality Testing
* Validating test methods.
* Ensure that maintenance records and process adjustments records are maintained and captured in real time.
* Ensure all CAPAs under your responsibility are completed in compliance with all regulatory and procedural commitments.
* Participate in the Change Control Process.
* Devise and implement Six Sigma continuous improvement projects.
* Write specifications.
* Analysis of data, quality metrics and trends
* Liaise with relevant personnel regarding flow of product through QC department and other issues that arise
* Preparation, review and approval of technical documentation.
* Manage and provide support with ongoing changes and continuous improvement projects e.g. Project Win SPC, automated machine
* Perform training as required
* Maintain costs and budgets under control
* Ensure the smooth running of functions under your control
* Review, analyze and report on relevant customer complaints and institute corrective actions
* Become an active member of the site internal audit team, liaising with Regulatory auditors, perform audits and write reports

Qualifications
Educational Requirements:
* Third level qualification in a Science/Engineering discipline (Preferably Polymer Science/Engineering or Mechanical Engineering)
Relevant Experience:
* Good knowledge and application ISO or ISO 13485 environment, coupled with a knowledge of FDA regulations and other standards.
* Good experience in the preparation of Technical Documentation.
* Good knowledge of Statistical Process Control and sampling techniques and standards
* Good knowledge of SAP and Track wise.
* Good experience in CAPA system management, incident report and MRB
* Good experience in Validation
* Good Experience in complaints analysis and reporting
* A working knowledge of FDA requirements and managing FDA audits.
* Experience in moulding, process validation and working in a clean room environment.
* Proven ability of working in a cross-functional team environment.
* Excellent interpersonal and communication skills.
* High level of computer literacy.

If you are interested in hearing more about this excellent opportunity please respond with an updated CV for immediate consideration.
Start date
10/2015
From
Real Staffing
Published at
03.10.2015
Project ID:
993914
Contract type
Permanent
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