Senior Quality Engineer
Our client, a manufacturing company in Galway are currently looking to recruit a Senior Quality Engineer for their site.
Duties & Responsibilities
- 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 SME's 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
- Provides additional support and assistance on tasks and projects as directed by management
- The candidate will be experienced in developing; CAPA, NCMR systems and control plans ensuring that performance and product quality conforms to company SOP's, customer and regulatory guidelines. This is a lead role and will require the candidate to have people management experience.
- 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.
- Strong working knowledge of Quality Management Standard
- Proven experience of Lean manufacturing / six sigma is highly desirable.
- Lead Auditor certification desirable
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