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Design Assurance Quality Engineer

Job in Galway - Ireland
Posted by FRS Recruitment
Full Time position (Ref. #FRS23283)
Listed on 2019-09-28
Job specializations:
  • Engineering
    Quality Engineering, Engineering Technology
  • Quality Control
    Quality Assurance, Quality Manager
Job Description & How to Apply Below
Title: Design Assurance Quality Engineer
Location: Co. Galway (East)
Working hours: Monday - Thursday, 39h/week
Reporting to: Quality Manager/ Senior Design Assurance Engineer
Salary: attractive package, including benefits

Job description
Provides guidance and supports all activities pertaining to the design, development and qualification of new products. Coordinates and prepares product submissions to obtain global approvals for commercial distribution.

Main responsibilities
* Interfaces with R&D, Clinical, Marketing, Process Development, Regulatory and Manufacturing to provide technical and quality systems input to new product designs.
* Implements and maintains Design Assurance policies and procedures.
* Provides training on the policies and procedures required to support Design Control.
* Provides the Quality review at defined design review phases to ensure compliance with all required regulatory requirements.
* Generates product risk analysis documentation (design FMEAs) and ensures risk continuity through to process FMEAs.
* Generates associated design plans, protocols and reports for new product development projects as well as design / process changes.
* Compiles the required regulatory data to support new product submissions and notice of change for the global marketplace.
* Provides Design Assurance continuity across development / transfer projects in line with policies and procedures.
* Generates device labeling and advertising materials for compliance with applicable regulations.

Requirements and Qualifications
* Primary degree or equivalent work experience, preferably in a scientific or technical discipline.
* 3 + years Quality Engineering / Design Assurance experience in the medial device or pharmaceutical industry.
* Thorough knowledge of product development process and design control requirements (product risk analysis, design FMEAs, process FMEAs, design validation, test method development / qualification and statistical techniques).
* Thorough understanding of FDA, European, Japanese and other international regulatory requirements.
* Ability to coordinate multiple projects.
* Excellent written and oral communication.
* Strong organizational, interpersonal and influencing skills.

To apply for this temporary position, please submit your CV (in Word) through this website now in the strictest of confidence.
Position Requirements
Contact Information
Contact Name: FRS Recruitment
Preferred method of contact: Email with CV via Application Box below.
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