Quality Engineer
On behalf of our Life Science company in Shannon, we are currently sourcing a Quality Engineer to join their Team. The successful Candidate will apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and the Company's systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.
Key
Responsibilities:
• Investigate moderately complex manufacturing
product quality and compliance issues (e.g., CAPA, non-conformances, audit
observations) for all production processes prior to final product release based
on engineering principles; analyse results, make recommendations, and develop
reports
• Optimize manufacturing 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, update, and maintain technical content of
risk management files.
• Develop training and documentation materials for
production (e.g., work instructions) to enable the seamless knowledge transfer
of project and manufacturing processes.
• Assign support tasks; gives instruction to
technicians on conducting tests; trains technicians and provides feedback; and
may coordinate technician work
Education
and Experience:
Bachelor's Degree in Engineering or scientific field,
minimum of 3-4 years’ experience Required
Additional
Skills:
• Good computer skills in usage of MS Office Suite;
CAD experience preferred
• Good documentation, communication, and
interpersonal relationship skills
• Basic understanding of statistical techniques
• Previous experience working with lab/industrial
equipment required
• Solid understanding and knowledge of principles,
theories, and concepts relevant to Engineering
• Solid problem-solving, organizational, analytical,
and critical thinking skills
• Solid understanding of processes and equipment
used in assigned work
• Knowledge of and adherence to Quality systems
• Strict attention to detail
• Ability to interact professionally with all
organizational levels
• Ability to manage competing priorities in a fast-paced
environment
• Must be able to work in a team environment,
including the ability to manage vendors and project stakeholders
• Ability to build stable working relationships
internally
If you have the above skills & experience please contact darren.brown@cpl.ie / 087
405 3774