Job Details  
Advertiser: CareerWise Recruitment

Job Title: Senior Quality Engineer
Rate:£0 Per Year
Description: A Senior Quality Engineer is required by CareerWise Recruitment for our Galway based client. Based in Galway, reporting to the Quality Manager and, as a lead role, People Management is an essential part of the role.Please contact Tom Devaney for more information.

* Manage key elements of the Quality System to ensure compliance to relevant standards for the business including EN ISO13485, FDA QSR.
* Coordinate the Internal Audit system and Audit Team to ensure that all audits are completed in a thorough and timely manner. Conduct Quality Audits as necessary.
* Lead preparation and coordination activities for external audits and liaise as required with SMEs to ensure audits are conducted in an efficient manner.
* Manage all aspects of the Document Control Function in conjunction with the appropriate resources.
* Responsible for generating Quality Performance data with the goal in identifying opportunities for improvements (CAPA).
* Identifies any opportunities for improvement within the quality system procedures and practices in association with the appropriate internal groups.
* Coordinate the Non-Conforming and CAPA system to ensure that all NC/CAPAs are completed in a thorough and timely manner.
* Leading and managing investigations providing a formal structured approach to identify root causes, establish corrective actions and execute prevention plans in products and/or processes.
* Use knowledge of statistics to assist with process improvements, validation developments and process/product investigations.
* Assist with the development of suppliers to provide reliable, trustworthy and productive relationships
* Perform supplier compliance and qualification functions and activities for prospective new Commodities, Purchased Finished Goods and Critical Service suppliers.
* Perform supplier development activities with suppliers of defective materials including developing and executing Supplier Quality Plans, conducting For-Cause Audits, Supplier Corrective Action follow-up, coordinating Business Reviews, and implementing Six-Sigma and Continuous Improvement methods and techniques.
* Resolve ineffective supplier corrective action plans with suppliers.
* Close liaison and networking with other departments, to provide and drive quality inputs and initiatives into the overall operational activities of the company.
* Identify and initiate action to address any adverse trends or regulatory compliance issues in a timely manner.
* Support the implementation of Company Policies and GMP

* Degree in Science or Engineering or similar technical discipline.
* 7+ years experience in Quality function, of which 3+ years experience in a Quality Engineering role with medical devices in FDA regulated environment.
* The candidate will be experienced in developing; CAPA, NCMR systems and control plans ensuring that performance and product quality conforms to company SOPs, customer and regulatory guidelines.
* This is a lead role and will require the candidate to have People Management experience.
* Strong working knowledge of Quality Management Standard
* Proven experience of Lean manufacturing / six sigma is highly desirable.
* Lead Auditor certification desirable.

CareerWise Recruitment accepts that you do not wish your CV to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will be respected at all times.

Please call Tom Devaney today for further information on 091-758771 or email:

CareerWise Recruitment
In Search of Excellence
We provide recruitment services in the areas of Engineering, Supply Chain, Sciences, IT and Accounting & Finance.
We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway and Dublin.
Supporting Business Demands & Growth since 1999
Skills Required: Senior Quality Engineer, Quality Engineer, 13485, SQE
Job Type: Permanent
Start Date: 07/02/2018
Contact: Tom Devaney Contact E-mail: Click
Contact Tel: 00 353 91 758771 Contact Fax: +353 61 364985
Reference: CW121153 Added: 07-02-2018
  IMPORTANT: For jobs based in the UK it is unlawful to employ a person who does not have permission to live and work in the UK. Please ensure you have this permission before applying, unless the advert states otherwise.
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