Quality Engineer

Job Description

I am currently seeking a quality engineer for a well-known company based in Dublin. This person will oversee and ensure the timely and efficient closure of internal and external quality issues.

To be successful in this role you will have a degree or qualification in an engineering, science or quality related discipline with minimum 2 years working in a medical device manufacturing industry. You will have excellent knowledge and exposure to ISO 13485 with further knowledge of 21 CFR Part 820. Auditing experience to the requirements of the above would be advantageous. It would be desirable to have prior experience or understanding of plastic process manufacturing. An in-depth knowledge of validation and change control management in a medical device environment is essential. Experience with Minitab also a key requirement.

Responsibilities:

• Liaise with customers to ensure concerns or complaints are efficiently communicates and CAPAs are closed out in a timely manner.
• Drafting and approval of quality documentation to meet customer requirements including quality specification sheets and CAPAs.
• Management of documentation into the quality system including quality agreements.
• Track quality data to support quality improvements.
• Lead investigations into issues to ensure root cause analysis and CAPAs are implemented.
• Adhere to incoming control requirements.
• Participate in review of validation protocols and reports.
• Support internal and system audits.
• Support and manage quality projects to support continuous improvement initiatives.
• Liaise with other divisions in the business to ensure smooth operations.
• Drive culture of compliance and CI.
• Batch paperwork review and decision to release for shipment.
• Adhere to company and regulatory standards and guidelines

If this role is of interest, please 'apply now' or contact me on 021 2300 300 or at aodriscoll@morganmckinley.com

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

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