Our client, a global leader in medical devices is recruiting for a Quality Engineer for their site in Shannon
The Quality Engineer applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Companies systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.
- Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.
- Implementation of product verification processes post sterilization, equipment and SOP setup.
- Pre-post sterile correlation studies experience.
- Test method validations, installation qualifications and tool/fixture qualifications.
- Identify and ensure the optimization of complex Manufacturing and/or R&D processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement.
- Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.Develop training and documentation materials for production (e.g., work instructions, certifications).
- Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
- Train, coach, and guide employees on routine procedures.
Qualifications and Experience:
- A Bachelor’s degree in Mechanical, Biomedical, or equivalent engineering degree is required.
- Minimum of 4 years’ experience in Quality or Manufacturing is required.Proven expertise in usage of MS Office Suite preferred.Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills.
- Proven knowledge and understanding of statistical techniques, minitab.Working knowledge of design verification/validation processes preferred.
- Previous experience working with lab/industrial equipment required, e.g. Instron
- Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering.
- Strong problem-solving, organizational, analytical and critical thinking skills.
- Substantial understanding of processes and equipment used in assigned work.
- Knowledge of and adherence to Quality systems.
- Strict attention to detail.
- Ability to manage competing priorities in a fast paced environment.Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects.
- Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations.
- Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control.
For further information on this Quality Engineer role in Shannon please contact Orla Crowley on 0860449473/ Talent@hero.ie
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