Description
I have a fantastic opportunity for a Senior Quality Engineer with a leading medical device company based in Athlone. This is an excellent opportunity to join a growing company in a senior role with lots of opportunity for career progression.Responsible for: Providing Quality support to processes, materials, and products. Assuring Quality standards are maintained and assist with the implementation of and compliance to the Quality Management program and for supporting company goals, objectives, policies, procedures, quality systems and compliance with regulatory requirements (ISO, FDA, JPAL and other agencies as applicable).
Major Duties and Primary Responsibilities:
* Complete new supplier evaluation and qualification.
* Liaises with suppliers to ensure drawings and specifications are clear, understood and fully compliant.
* Implement and improve metrics for supplier performance and incoming inspection
* Complete vendor audits
Manufacturing Quality
* Validation experience
* Liaise with Manufacturing Engineering on the completion of risk assessment, Work Instruction updates, and FMEA's for any product line extensions, process improvements for new and existing products.
* Review and/or develop and execute facility, software, process and equipment validations and risk management documents.
* Review change controls for validation impact.
* Use knowledge of statistics to assist with validation developments and process improvements
* Provide quality support to Manufacturing Engineering with sampling plans, data processing or analysis for validation for new and existing product lines.
* Assist in the analysis and resolution of problems that may reduce the efficient running of production lines.
* Provide quality support to Manufacturing Engineering with NCMR and CAPA investigation, processing and disposition.
* Ensure continuous compliance for Product Manufacturing, Packaging and Labeling.
* Perform Internal Audits.
* Assist in the development, analysis and improvement of site Quality Metrics.
* Will abide to Environmental, Health and Safety (EHS) Policies and any relevant other EHS documentation.
* Will comply with all relevant training required and adhere to relevant associated documentation.
* Follow strict adherence to the requirements of CGMP.
* Actively contribute to the enhancement of compliance initiatives for areas of responsibility.
Education:
* Degree in Engineering or Science or minimum 5 years experience in a Medical Device environment.
Experience:
* Five (5) years experience working in a regulated environments, specifically medical device, FDA or ISO 13485 registered work environments.
Skills:
* Strong computer skills (MS Excel, PowerPoint, Word etc)
* Familiarity with statistical tools such as Pareto charts and trend charts.
* Familiarity with FMEA's (Failure Mode and Effects Analysis) and root cause analysis tools.
* Experience with problem solving techniques
* Ability to effectively communicate highly technical information, both verbally and in writing, to both non-technical and technical associates.
If you are interested in hearing more about this excellent opportunity please apply directly to this advert or contact Derek Sheridan on for immediate consideration.