Quality Engineer Reference: JOM ARDX-683470 Location: Wexford Qualification: Degree Experience: 1-2 Years Job Type: Permanent Salary: Not Disclosed Job Description:
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 teamsDevelops process risk management documentation with cross-functional supportDevelops or assists in development of inspection and test methods per product specifications.Performs test method validations as requiredIdentifies quality systems engineering improvement opportunities and executes through the change management systemEnsures 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 MDRExperience in Risk Management process – PFMEAKnowledge of Gauge R&R and Test Method Validation for Physical & Mechanical Test MethodsExcellent attention to detail and adaptabilityExperience 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 deadlinesProblem-solving techniques with excellent organisational skillsExcellent 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 ****** or ring 087 189 7333.
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