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Joan O'Malley
Life Science

0871897333
[email protected]
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Details

Quality Engineer


Reference:JOM ARDX-683470 Location: Wexford
Qualification:DegreeExperience:1-2 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Quality Engineer

JOM ARDX-683470 Quality Engineer


Wexford

You will support process Transfer of peripheral interventional devices, new products and delivery systems from manufacturing or R&D to the Manufacturing site. This role will represent quality interests and concerns on project teams, assuring that new products and the processes meet all local, divisional and corporate requirements with respect to safety and efficacy. You will be responsible for the execution of the technical tasks of the transfer following an established transfer process. This will involve the different phases of a project including risk management, test method development and validation, qualification and launch of the product. The role will work closely with the different functions onsite and between sites.

This is an initial 18 month contract role


Other Responsibilities may include, however are not limited to: 

    • Leads the Quality engineering activities for transfer projects, supporting and participating in NPI teams
    • Develops process risk management documentation with cross-functional support
    • Develops or assist in development of inspection and test methods per product specifications.
    • Performs test method validations as required
    • Identifies quality systems engineering improvement opportunities and executes through the change management system
    • Ensures regulatory / statutory / legislative compliance for all project work.
Required Qualifications
    • Education: Bachelor of Mechanical, Biomedical, Chemical or other related engineering discipline or Technical/Science qualification (level 8).
    • Experience: 2+ years of industrial experience in quality engineering or similar, preferably in medical device or other regulated FDA/QSR and ISO environment.
    • Familiarity with regulations including ISO 13485, CFR 11820, ISO 14971 and EU MDR
    • Experience in Risk Management process – PFMEA
    • Knowledge of Gauge R&R and Test Method Validation for Physical & Mechanical Test Methods
    • Excellent attention to detail and adaptability
    • Experience in process validation (IQ, OQ and PQ) is a plus.
    • Excellent interpersonal skills with the ability to work in a team environment and work under own initiative to targets and deadlines
    • Problem solving techniques with excellent organisational skills
    • Excellent oral and written communication skills.
    • Ability to analyze data, interpret results, and write reports. Proficient in statistic software is a plus.


Any applicant must have a valid work permit, stamp 4 or an EU passport to apply.
Reach out to [email protected] or ring 087 189 7333.