Design Assurance Engineer
|Job Title:||Design Assurance Engineer|
|Contact Name:||Larry O’Leary|
|Job Published:||over 1 year ago|
Our client, a medical devices manufacturer based in Galway, now seeks a Design Assurance Engineer who will be responsible for the design, development and qualification of new products.
The successful candidate will coordinate and prepare product submissions to obtain global approvals for commercial distribution.
This role will Interface with R&D, Clinical, Marketing, Process Development, Regulatory and Manufacturing to provide technical and quality systems input to new product designs.
Responsibilities of Design Assurance Engineer
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 for Design Assurance Engineer
Bachelor's Degree in a scientific or technical discipline (level 8)
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).
Proven understanding of FDA, European and other international regulatory requirements.
Ability to coordinate multiple projects.
Excellent written and oral communication.
Strong organizational, interpersonal and influencing skills.
Please phone Larry on 01-2302400 / firstname.lastname@example.org / www.rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.
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Key words: Medical devices, regulatory, design assurance, product development, PFMEA, FMEA, design control, design verification, validation, Galway, Clare, Westmeath.