Quality Validation Engineer
Posted on Jan 6, 2021 by Real Staffing Group
Job title: Quality Validation Engineer
Location: Macroom, Cork.
Benefits: Excellent career progression opportunities, Salary, Bonus, pension and healthcare.
As a Quality Validation Engineer you will be supporting the validation, change management, in process monitoring and maintenance of the special processes utilized as well as all other equipment validation work completed. Particular focus will be placed on the Critical In Process and Final Cleaning processes.
Medical device company specialising in Orthopaedic products who are growing through an exciting growth phase.
- Characterization study/Diagnosis creation and execution when applicable.
- Review and execution of process validations related to special processes ensuring compliance to all internal requirements as well as FDA and ISO regulations.
- Review and approval of validation documentation related to all other new equipment.
- Identify and implement cost saving initiatives related to the validation process.
- Develop and implement comprehensive test plans as well as test methods to ensure that special processes are robust and remain within the validated state.
- Establish and track manufacturing requests relative to testing sample requirements
- Be the Quality Engineering Operations point of contact for production when risk assessing or troubleshooting new and existing issues related to the special processes whether that involve design, materials or equipment, and provide creative, timely, and cost-effective solutions. 8. Support Quality for non-conformities and CAPA relatives to special processes
- Represent Quality Engineering Operations on validation related projects, give guidance on approach taken and establish associated reporting.
- Support QA and RA groups during audits, inspections and authorities responding when related to special processes and especially Critical In Process and Final Cleaning processes.
- Minimum Level 7 Degree level qualifications in a related technical discipline.
- Minimum of 4 years' experience working in a similar engineering role and/or have equivalent process validation experience.
- Technical knowledge on Critical Cleaning processes and the execution of ISO 19227 and related requirements.
- Lean and Six Sigma qualifications are an advantage.
If you are interested in applying or have any questions about this role forward me your updated CV or get in touch and we can organise a call to discuss further.
Look forward to hearing from you.
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales