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quality design engineer

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Limerick, International
Job type:
Date Posted:
11 September 2019
reference number:

Are you an experienced Quality Design Engineer? Are you looking for an exciting new opportunity? Do have experience working with medical devices? If the answer is yes, then this role is for you!

As a Quality Design Engineer you'll be responsible for the new product development and maintenance. Ensuring all quality standards are meeting quality control standards. You'll be working for a global medical technological company and be responsible for the design and development of Infusion Pumps.

This role is based in Limerick and on a permanent basis.

* Gym and shower facilities on site.
* Accessible on-site staff parking.
* Site canteen.
* Staff break-out areas.
* Health care cover -Includes dependents
* Defined contribution pension, with an employee contribution rate of 5%, and employer contribution rate of 9.75% of salary
* Eligibility to partake in Global Share Investment Program
* Life Assurance cover
* 24 days annual leave plus 9 days public holidays

Main Responsibilities:
* Be a Design Assurance Quality Engineer on the project core teams.
* Responsible for product quality, DHF documentation, compliance, patient safety, customer satisfaction.
* Adaptively apply working knowledge of quality engineering concepts within the product lifecycle.
* Writing various project quality plans
* Lead risk management activities within the project.
* Participate within project core Teams to test protocol definition based on applicable specification and relevant requirements.
* Review and approve test protocol and reports. Review and approve related execution deviations.
* Assist / conduct Failure investigations and problem-solving sessions
* Review and challenge statistical rationale, plan and data analysis in the frame of test protocols.
* Review quality objectives and goals that have been identified and ensure they are sufficiently defined in specifications, procedures, and testing.
* Ensure process validation activities are completed appropriately and make the link with product design whenever needed.
* Conduct quality functional reviews and DHF compliance reviews.
* Ensure compliance across projects for design control, risk management and change control processes.
* Support Quality culture within R&D organization while providing training on applicable requirements.

* Must have a Bachelor's Degree in Engineering; Electrical or Mechanical Engineering is preferred
* Have over 5 years of medical device quality engineering experience.
* Must have R&D experience.
* Expertise in design assurance including design controls and risk management
* Have embedded software validation experience.
* Have experience working with Capital Equipment validation
* Ability to act as Change Agent and effectively manage change
* Experience working with cross-functional teams and remote teams, promote work in multidisciplinary teams.

Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.

Candidates must be eligible to live and work in the UK.

For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.