Job Description
We are seeking a Senior Quality Engineer to join our growing team at a global medical device company based in Dublin.
This is an exciting time for the company as we continuously grow with new and existing projects in the pipeline.
The Senior Quality Engineer will support design control activities, utilizing problem-solving approaches and analytical skills to support NPD and product maintenance.
The ideal candidate will have minimum 5 years' experience in a similar role, coming from the Medical Device and/or pharmaceutical industry, with a degree in engineering or science.
An excellent understanding and knowledge of industry and regulatory standards, including ISO 13485, QSR, GMP, are essential.
Prior experience working with quality systems, six sigma methodology, validation, and risk management is desirable.
You will be able to manage multiple projects and evaluate them throughout.
Senior Quality Engineer Responsibilities:
* Assist and conduct Failure Investigations and problem-solving sessions for non-conforming products Reviews.
* Lead a team of quality technicians.
* Quality Engineering approval authority for new and modified design/process specifications, including product performance specifications, test methods, and process validation.
* Consult with Manufacturing Plants.
* Lead risk management activities.
* Ensure design control elements are satisfied.
* Ensure/perform process validation activities.
* Support supplier qualification activities – risk classification assessment and product quality assessments.
* Evaluate test methods used in project activities.
* Evaluation of customer requirements to identify applicable quality standards.
* Release product (customer samples) during development activities.
* Realization of quality functional reviews.
* Ensure implementation of Pharmaceutical Systems global procedures and standards for QE engineering activities.
* Provide support to internal, regulatory body, and customer audits and associated corrective actions.
* Supports continuous improvement of current products and practices to improve quality, customer experience, and worldwide market share.