Avenue - a Nolato company based in Finisklin Business Park, Sligo is an award-winning mould-building company, and a growing medical device precision injection moulding business that has been successfully serving Ireland and the broader European markets for 30 years. Avenue also brings expertise in building ultra-high-cavitation tooling for the medical device, diagnostics, and pharmaceutical markets.

The QA Validation Engineer will support the Validation, Quality, and Metrology departments.

SPECIFIC RESPONSIBILITIES

• Generation, maintenance, execution and completion of process, systems, moulding machines, and equipment validation and/or revalidation in accordance with Project Validation plans, schedules and Company policy.
• Coordinate with the Operations, Engineering, NPI & Project teams to ensure validation and/or revalidation activities are appropriately planned to coincide with the overall implementation timelines.
• Prepare, execute, and complete Validation Protocols and Reports, ensuring compliance to all relevant Quality Standards and Regulatory requirements.
• Be an integral role in decision making relating to validation and/or revalidation activities at the site.
• Ensure consistency on validation/qualification approach across processes, systems, and projects with adherence to company validation procedures.
• As needed, liaise directly with customers regarding queries and issues.
• Provide validation expertise and guidance on overall validation strategy for all activities requiring validation on site, ensuring compliance, as applicable, with ISO13485 and all other Quality Standards and Validation documents.
• Support process validation quality activities as part of an overall Project, Engineering & NPI teams.
• Manage the execution of approved validation protocols, requiring product sampling and strong communication skills.
• Draft and review validation protocols and reports in line with internal and regulatory requirements.
• Review and approve validation documentation for systems, equipment and manufacturing processes.
• Prepare quality related documentation for NPI projects through validation stages e.g., Standard Operating Procedures, work instructions, test methods and Batch records.
• Review and approve changes to equipment, process, utilities, methods, and systems to ensure the validation status of equipment is maintained.
• Troubleshoot/investigating validation related deviations
• Carry out statistical analysis of data and generate reports as required.
• Training and communication of validation protocols and activities to the relevant departments.
• Any other duties to support the Quality and Validation function as directed by the Quality and Regulatory Affairs Manager.

QUALIFICATIONS

• Degree in Quality and/or Engineering or a relevant technical discipline essential.
• 3 years relevant Validations experience in the medical device/ manufacturing industry.
• Computer Software Validation experience is desired.
• Excellent attention to detail, problem solving and strong communication skills.
• Computer proficient in MS Word and Excel. Previous experience with Minitab is preferable.
• Proven Self-Starter with previous experience working on own initiative.