Senior Validation Engineer – Limerick

Senior Validation Engineer – Limerick 

Great opportunity for a Validation Engineer to join a thriving Medical Device company in Co. Limerick. Working on and Validating the latest Medical Device technology and equipment in Quality Validation role. 

Responsibilities

• Write, review and/or approve validation protocols and reports (e.g., cleanroom, equipment, test method and product transfer validation protocols) in accordance with applicable Regulations, SOPs and Good Documentation Practices (GDP) Utilise test equipment to verify equipment parameters, process outputs or product outputs. Anticipate risks of execution and put mitigations in place so audit review requirements are met.  Analyse data and perform statistical analysis to ensure validation meets predefined acceptance criteria. Work with cross-functional partners to implement comprehensive preventative maintenance work instruction as well as revalidation requirements. Write Validation Plans for projects that require multiple validations and create timeline for validation
• Collaborate with cross functional teams to implement and align Quality Control inspection plans, requirements, and methodologies.
• Provide daily direction and guidance to manufacturing processes and personnel.
• Work with production and inspection staff to analyse, evaluate, understand and resolve any assembly inconsistencies or product/production issues.
• Review and disposition Non-conformance reports. Perform Root Cause analysis in order to determine corrective and preventive action activities
• Ensure appropriate process outputs and process controls are translated into Quality Control Plans, Work Instructions and Device Records
• Establish a Receiving Inspection function including writing and implementing procedures, hiring and supervising Inspection technician to support product and receiving inspections.
• Evaluate risk, manage risk assessment activities and create associated documentation
• Investigate and implement solutions to audit findings
• Manage Supplier Quality activities as needed.
• Perform supplier evaluations including on-site audits to assess supplier capabilities, determine approval status, and verify corrective action
• Evaluate supplier Quality systems, strategies and regulatory compliance via vendor audits
• Partner with Suppliers, as appropriate to identify and define corrective actions and follow-up to ensure completeness and effectiveness of Supplier improvements to meet Edwards and applicable regulatory requirements.
• Other incidental duties assigned by Leadership

What You Will Need

• Degree in Engineering or related field
• Basic understanding of statistical techniques.
• Manufacturing Engineering and/or Process Validation background preferred
• Proven ability to apply Engineering/Scientific theory
• Strong problem-solving, organizational, analytical and critical thinking skills
• Excellent verbal and written communication skills in English.
• Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills

For more information on this excellent opportunity get in touch with Gary Keane
Call: 091-700814
Email: garykeane@cregg.ie