Role Purpose
To lead and execute validation activities for medical devices, ensuring full compliance with applicable regulatory standards and quality system requirements.
Key Responsibilities
- Manage and execute process and software validation activities in a regulated medical device environment.
- Serve as the primary point of contact for all validation execution activities on-site in Fermoy.
- Investigate and resolve validation-related issues effectively and efficiently.
- Standardize validation and qualification practices across all projects and systems.
- Provide technical direction and support for the development, execution, and review of validation protocols and documentation.
- Maintain up-to-date knowledge of current GMP and regulatory requirements to support compliance across the site.
- Oversee the validation lifecycle, including scheduling and conducting Periodic Reviews.
- Support change control processes related to process and facility modifications.
Quality Responsibilities
- Ensure validation practices meet internal quality standards and external regulatory requirements.
- Assist in audits and inspections, providing validation documentation and expertise.
Health & Safety
- Adhere to all relevant Health & Safety regulations, ensuring safe execution of validation activities.
Performance Indicators
- Timely, accurate completion of validation tasks and documentation.
- Demonstrated compliance with applicable regulatory and quality standards.
Qualifications & Experience
Required:
- Level 7 qualification (QQI) in Science, Electronics, Mechanical, or Industrial Engineering.
- Minimum of 2 years’ experience in Quality Assurance or Regulatory Affairs.
- Practical experience in conducting Process Validations aligned with CDRH Guidance.
- Proficiency in GAMP 4/5 software validation methodologies.
- Strong problem-solving and analytical skills.
- Skilled in Microsoft Word, Excel, and PowerPoint.
- Ability to draft SOPs, training materials, and regulatory submissions.
- Experience with statistical tools, Design of Experiments (DOE), and DMAIC.
Preferred:
- Experience in a regulated Medical Device Manufacturing environment.
- Fluency in German.
- Certified Six Sigma Green Belt or Black Belt.
- Knowledge of electronic manufacturing processes.
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