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Job Details

Design Assurance Engineer

Company: Thornshaw Recruitment
Location: Galway
Reference: DB9625
Closing Date: 21 Dec 17
Type: Permanent
Salary (£): On Application
Benefits:

Job Summary:

Design Assurance Engineer opportunity with expanding medical device company!

Requirements:

You will provide guidance and support all activities pertaining to the design, development and qualification of new products. You will coordinate and prepare product submissions to obtain global approvals for commercial distribution.

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.

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.

For a full Job Spec and to apply for this role please call Deirdre on +353 1 2784671 or e-mail dbolger@thornshaw.com


Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Www.thornshaw.com Tel: +353 1 2784671

Apply for this job: Design Assurance Engineer

Contact Information:

Address:  Head Office
Barton House 6 Old Dublin Road Stillorgan Co. Dublin

Rep. Ireland
Tel:  00 353 (1) 278 4671
Fax:  00 353 (1) 278 4672
Website:  Visit Our Web Site

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