Design Assurance Engineer

Design Assurance Engineer (6 month contract)

Ref No.: GJ07895aa

Location: Galway, Mayo, Westmeath

Salary:

Experience required: 3 - 4 years

Job Type: Contract



Summary: Our client is one of the leading manufacturing companies they currently have a requirement for a Design Assurance Engineer based in Galway.



Description:

Design Assurance Engineer (6 month contract)

Our client is one of the leading manufacturing companies they currently have a requirement for a Design Assurance Engineer based in Galway.

Responsibilities

Maintain assigned aspects of the quality system.

Participate in assigned project team activities as follows:

Reresent the requirements of the quality system and regulations in relation to all project activities.

Oversee the development of design assurance and test programs

Develop test protocols and reports as required by the project.

Manage risk management activities

Participate in manufacturing quality activities, where assigned, as follows:

Represent the requirements of the quality system and regulations in relation to all aspects of manufacturing

Ensure an effective inspection system is in place to assure product quality

Monitor manufacturing compliance with system and regulatory standards

To disposition product, components and sub-assemblies in compliance with regulatory requirements.

To prepare and submit regulatory and clinical documentation as required.



Requirements

A minimum of five years relevant experience in the medical device or pharmaceutical industry.

Good familiarity with quality system, regulatory submission and design assurance activities.

A diploma level qualification, or higher, in Engineering, Science, QA or related field is essential.

ood communication skills, computer literacy and the ability to present reports neatly and accurately are essential.

A thorough understanding of ISO13485:2003 and the FDA QSR’s is a prerequisite