Senior Quality Engineer (Medical Devices)

CREGG; Limerick; On-site; EUR 50,000 - 70,000; Full time

Job summary

CREGG is seeking a Senior Quality Engineer to join a medical device manufacturing client in Limerick, Ireland. This role includes establishing quality engineering principles, investigating product quality issues, and developing training materials. Candidates should have a Bachelor's Degree in Engineering or a Scientific field and at least 4 years of relevant experience. This position offers a chance to work in a dynamic environment focused on compliance and process optimization.

Qualifications

• 4 years minimum of industry or industry/education related work experience.

Responsibilities

• Ensure compliance with regulatory requirements and systems/procedures.
• Investigate manufacturing product quality and compliance issues.
• Optimize manufacturing processes using engineering methods.
• Develop training and documentation materials.

Skills

Quality engineering principles

Six Sigma

Lean methods

Problem-solving

Education

Bachelor's Degree or Equivalent in Engineering or Scientific field

Job description

Senior Quality Engineer (Medical Devices)

CREGG has an exciting opportunity for an experienced Quality Engineer to join their Limerick based medical device manufacturing client.

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
• Investigates 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; analyzes results, makes recommendations and develops reports.
• Identifies and ensures 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. Identifies opportunities for re‑design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.
• Develops, updates, and maintains technical content of risk management files.
• Develops training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes.
• Assigns support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
• Trains, coaches, and guides lower level employees on routine procedures.
• Interacts with senior internal and external personnel on significant matters often requiring coordination between organizations.
• Adheres to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and takes adequate control measures in preventing injuries to themselves and others as well as protecting the environment and preventing 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