Senior Quality Engineer (Medical Devices)

CREGG have an exciting opportunity for an experienced Quality Engineer to join their Limerick based medical device manufacturing client. Please call or email Rachel on 0860127415/[email protected] to discuss.

Responsibilities

• 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
• Investigate 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.
• 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, 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
• Train, coach, and guide lower level employees on routine procedures.
• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) 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

Requirements:

• Bachelor's Degree or Equivalent in an Engineering or Scientific field
• 4 years min. of industry or industry/education related work experience Required

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