Validation & Quality Engineer

Job Title: Validation & Quality Engineer

Salary: €Excellent

Benefits: To be discussed at interview - work life balance, profit share scheme

Job Type: Permanent

Location: Tinahely, Co. Wicklow

Job Start date: ASAP

Shift Pattern: Monday to Friday, Days

We're supporting our client, a leading Injection Moulding manufacturer based in Tinahely, who are looking for a Validation & Quality Engineer to join their growing team. The successful Validation & Quality Engineer will have experience of validation activities, ISO13485 and Quality procedures.

Responsibilities for Validation & Quality Engineer:
• Assist with the planning, co-ordination and support for the execution of validation activities.
• Ensure compliance to ISO13485, Quality Procedures and GDP. Assist with training staff on documentation and procedures as required.
• The design, analysis and approval of IQ, OQ and PQ protocols and reports.
• Liaising with production and other departments to ensure adequate resources are in place to execute validation.
• Assist with ensuring validation timelines are accurate and achievable.
• As part of process improvement projects, prepare process validation protocols were appropriate.
• Create CMM programmes for products that are manufactured and generate SPC data for each production run.
• Assist with the handling of the documentation software and equipment validation.
• Assist with the monitoring and control of calibration within the company.
• Handling product and material trial documentation. Complete any dimensional studies that may be required in relation to trials or as specified by the customer.
• Support Department Managers with the understanding and implementation of GXP's such as GAMP - Good Automated Manufacturing Practices; GDP - Good Distribution Practices etc.
• Assist with the development and analysis of quality metrics.
• Assist in carrying out internal audits and external audits where necessary in relation to preparing for audits, corrective actions and audit close out.
• Support and lead continuous improvement programs/ projects as required.
• Assist with training as required such as induction or procedural changes to documentation such as work instructions, QAP's, QSS's etc. that may require training by liaising with shift QI trainers to aid with training completion.
• Complete certificates of conformance and batch summary reports after the completion of production runs.

About You:
• Science, Engineering or Quality degree would be most advantageous.
• Must be capable of using own initiative and requiring minimum supervision.
• Have a good level of computer skills i.e. Excel and Word.
• Good Communicator
• Good Interpersonal Skills

Job Application:

If you would like to be considered for the role of Validation & Quality Engineer, please apply with your full CV - or call us now. Whilst this position may not be of interest to you or suit your skills and experience, please don't hesitate to get in contact with a member of the team at Willcox Matthews to understand how we can support you.

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Candidates must be eligible to work and live in the UK