Barrington James are exited to post a fantastic opportunity for one of our close clients. This company is a Medical Device manufacturer. They are backed by some serious investors the industry and are looking for future support within their regulatory. This opportunity is perfect for someone who is ambitious, independent and wants to play a key role in working on the most innovative projects.
Key Responsibilities
Write and execute process validation protocols and reports for new product introductions and revalidations due to process /material improvements utilizing scientific / technical knowledge.
Developing and implementing solutions to sustain and improve the QMS.
Maintain and support compliance to ISO 13485 and ISO 14001 systems standards.
Participate in the site change control, ensuring that all changes to validated processes are effectively identified and implemented.
Generation of risk assessments, covering cleaning, validation, and process.
Review and execution of Factory Acceptance Testing and Site Acceptance Testing protocols.
Directly supports GMP and regulatory audits.
Prepare and deliver training modules as required.
Perform data analysis and make informed decisions / recommendations around conclusions reached from data analysis
Support continuous improvement through Lean Six Sigma methodologies.
Execution / development of change controls.
Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g., FMEA, Fishbone diagrams, 5 why’s etc.;
Implement subsequent corrective action through the change management system.
Participate / lead cross functional teams including liaising with vendors on projects.
Qualifications & Key Attributes
Third level qualification in Engineering, Polymer Science, or equivalent Manufacturing experience.
Experience in statistical analysis (Minitab) / SPC / validations.
Excellent interpersonal, communication, influencing, and facilitation skills.
A minimum of 2 years’ experience as a Validation Engineer within an Injection moulding or medical manufacturing environment.
Hourly rate: €60.00 EUR
Location: Longford, Ireland
This truly is an exiting opportunity for someone to join an ambitious company who are continuing to impress the market with their ground-breaking studies.
The opportunity has understandably been incredibly popular. We encourage all interested candidates to apply immediately as it is likely that recruitment will close prematurely.
By clicking "apply" you will be sending your CV to Charlie Denton at Barrington James. Charlie is a specialist Medical Device, engineering recruiter and will discuss the opportunity in detail with you, facilitate your application and will manage the process acting as a link between the company and yourself.
Please call +44 12 93 77 66 44 if you have any questions, alternatively you can reach Charlie on CDenton@barringtonjames.com
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