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Job ID: JOB-13420

Quality Engineer – Product Transfer

Our Wexford based client are hiring! This is an excellent opportunity for a Quality Professional to join an expanding Medical Device Manufacturer. 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

For further information on this role in Wexford please contact Mark Wilson on 0860449473 or email talent@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given.  You have supplied us with your personal data in the process of applying for a position.  Our client company may have personnel outside of the EEA who will review you data.  We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

Mark Wilson

JOB-13420

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