Telephone: 086 8395533
Senior Quality Engineer
Our client, a company in Galway is currently looking to recruit a Senior Quality Engineer for their site.
The Senior Quality Engineer is required to manage; process audits, 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, NCMR systems and control plans ensuring that performance and product quality conforms to company SOP's, customer and regulatory guidelines.
- Reporting to Quality Manager
- 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 coordination 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 in identifying opportunities for improvements (CAPA).
- Develop strong links with customer organisations and other project stakeholders.
- 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.
- 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
- Lead and coordinate preparing & on-going maintenance of FMEAs 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.
- The candidate will be experienced 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.
- 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.
- Clean room / controlled environment experience desirable.
- Lead Auditor certification desirable.
For further information on this Senior Quality Engineer role in Galway please contact Bimi Felix on 086 8395533 / email@example.com
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