Ref No: AM17653
County Dublin, Republic of Ireland
Quality Engineer - South Dublin.
About the role:
As directed by the Quality Manager, the Quality Engineer is accountable for supporting new product development and product maintenance through the application of Quality engineering skills for medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements.
This individual will be responsible for providing quality leadership, guidance, and support for new product development and sustaining engineering projects. You will work with other functions within the organization, such as R&D, Regulatory, Medical, Operations, and Marketing, to ensure regulatory compliance, satisfy business needs, and improve processes. This position requires the ability to handle multiple projects and tasks utilizing a high level of written and oral communication skills.
In this position, you may participate or lead in the following:
Design, Development and Quality Planning
Development of Technical Requirements and Product Specifications
Risk Management / FMEA
Design Verification and Design Validation
Test Method Development and Validations
Quality Functional Deployment (QFD)
Process Development and Validation
Sampling Plan Development
Manufacturing Quality Plan Activities
Design Transfer Activities
Design History File Management
Interested applicants should have:
BS degree in engineering or technical sciences. Master's preferred.
A minimum of 8 years' relevant experience.
Excellent knowledge of design controls and 21CFR820, ISO 13485, ISO 14971, ISO 10993 and applicable medical device regulations.
Class II medical device experience required.
Proficiency in risk analysis techniques (e.g. fault tree, FMEA) and experience leading others through process mapping exercises and coaching others in problem solving.
Demonstrated ability to make critical decisions regarding product quality or quality system compliance. Ability to assess and articulate risk when evaluating a situation.
Design for Six Sigma training and certification is desired along with knowledge of statistical methodologies.
Professional certifications (CQE, CQA, CRE) are desirable.
Excellent communication, problem solving, organizational and interpersonal skills are required.
Strong project management skills required.