Validation Quality Engineer

Validation Quality Engineer - County Cork.

The objective of this position is to formulate and execute validation plans for medical devices.

Responsibilities:

• Own and support validation activities in a medical device regulated environment.
• Responsible for all Process Validation Execution.
• Responsible for all Software Validation Execution.
• Resolution of problems encountered during validation.
• Ensure consistency in validation/qualification approach across systems and projects.
• Provide guidance and direction in the preparation and execution of validation activities.
• Be fully conversant and up to date with GMP requirements for site-wide regulatory body compliance.
• Maintain Validation system including conducting Periodic Reviews
• Participate in change control processes for manufacturing process and facility modifications.
• Assure ongoing compliance with quality and industry regulatory requirements
• Ensure compliance with Health & Safety Legislation and Regulations.

Requirements for this role:

• At least a QQI Level 7 Degree, preferably in Science, Electronics, Mechanical or Industrial Engineering
• Minimum of 2 years' Quality Assurance / Regulatory affairs experience.
• Experience in completing Process Validations as per CDRH Guidance
• Experience in using Gamp 4 or Gamp 5 Software V and V Techniques
• Sound understanding and utilization of problem solving techniques
• Proficient in the use of MS Word, Power-point and Excel.
• Ability to respond to common enquiries or complaints from internal customers and regulatory agencies.
• Ability to write standard operating procedures, training documents, and regulatory responses.
• Experience in Statistical Analysis / DOE and DMAIC methods.
• Experience in working within a Medical Device manufacturing environment is an advantage
• Ability to speak German an advantage
• Six sigma Green or Black Belt Certified is an advantage