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Senior Quality Engineer
Our client, a company in Clare 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.
- Education & Experience Required:
- 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.
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