- BBBH785628 Jun 25, 2021 Competitive
Excellent opportunity for a driven and passionate quality engineer to join a growing business. You will be directly involved with important site projects and gain great cross functional exposure
I am delighted to work with a fantastic company in Cork who are currently experiencing serious growth. Due to this they are looking for 2 x Quality Engineers to join their newly established MDR team on an initial fixed term basis of 18 months. This is a brilliant opportunity for an experienced QA professional to try something different from your standard operational QA role. This role will offer you exposure to important business projects and will also give you an introduction into the Regulatory side.
An overview of the role;
This position will support the execution of the Site's Medical Device Regulation Compliance by providing quality support to the MDR project manager. The successful individual will drive the flawless and compliant execution of the assigned processes to meet business needs while ensuring the quality processes are updated supported throughout the project.
An overview of the day to day;
- Work with cross functional team to generate documentation for technical file submissions.
- Is responsible for providing quality support and expertise to the project manager.
- Work directly with the various owners/teams across the globe to ensure investigations/actions are implemented and accurately documented to plan.
- Serve as technical expert with regard to questions or issues related to the processes, they are responsible for.
- Provides technical consultation to others pertaining to problems and leads technical project deliverables.
An overview of Education & Experience;
- Third level qualification (preferably Science or an Engineering related discipline) and 2 or more years of related experience (preferably within Medical Device)
- Knowledge of the applicable regulations and working knowledge of other major regulatory agencies regulations and guidance's is highly preferred.
- Previous experience or training in Process Failure Mode and Effects analysis desirable.
- Experience with delivering results through 6 sigma and lean methods. Ability to understand complex inputs and to be able to distil critical information.
- Strong analytical ability, relevant ERP knowledge (preferably SAP, Oracle or JDEdwards) and experience and strong PC skills (MS Excel, Access, etc.,).
- Proven ability to work in a diverse and dynamic team with excellent communication skills
- Experience with Technical writing would be a distinct advantage
If you are interested in this opportunity, or if you would like to find out more, reach out to Kellie today on 021 2300 300 or email@example.com
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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Senior Consultant | Engineering Recruitment - Quality & Validation
353 (0) 21 2300300