Senior Quality Engineer

ICDS Recruitment

Clare

Senior Quality Engineer - County Clare. In this role you will be required to manage process audits, and the development of Quality Management systems and associated documentation in the design and manufacture of medical device and associated products for global markets. The successful candidate will be experienced in developing CAPA and NCMR systems and control plans ensuring that performance and product quality conforms to company SOP's, customer and regulatory guidelines. Job Summary. • As a lead role, people management is an essential part of the role. • Manage key elements of the Quality System to ensure compliance to relevant standards for the business including ISO 13485, FDA QSR. • Provide quality input and support to the manufacturing, engineering, prototype and commercial functions. • Strategically lead new product introduction and contract reviews from a QA perspective. • Preparing and updating Operations procedures and associated documentation. • Overall responsibility for functional area GMP standards and compliance including the promotion of Quality Awareness. • Establishing inspection standards, plans, frequencies and test methods. • Lead preparation and co-ordination activities for external audits and liaise as required with SME's to ensure audits are conducted in an efficient manner. • Responsible for generating Quality Performance data with the goal of identifying opportunities for improvements (CAPA. • Develop strong links with customer organisations and other project stakeholders. • Co-ordinate 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. • 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. • Lead and co-ordinate preparation & on-going maintenance of FMEA's and Control Plans. • Quality review of functional area validation documentation. • Performing an active role in further development and continuous improvement of the quality management system. • Supervision and direction of Quality personnel. Interested applicants should beexperienced in developing Operations QA, CAPA, NCE 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. Education & Experience Required: • Degree in Science or Engineering or similar technical discipline. • At least 7 years' experience in a Quality function, of which at least 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. • Clean room / controlled environment experience desirable. • Lead Auditor certification desirable. This job originally appeared on RecruitIreland.com.

2133 days ago