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Senior Quality Engineer

Job Title: Senior Quality Engineer
Contract Type: Permanent
Location: Clare
REF: 94778
Job Published: 7 months ago

Job Description

Contact: Bimi Felix
Telephone: 086 8395533

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.
Duties & Responsibilities include but are not limited to:
  • 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.
Person Specification Overview:
  • 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.
For further information on this Senior Quality Engineer role in Clare please contact Bimi Felix on 086 8395533 /
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