Quality Engineer I Role Overview
A medical device company in Ireland is seeking a Quality Engineer I to join their growing team.
This role offers a unique opportunity for a motivated and hands-on quality professional to apply their engineering knowledge across multiple areas of a developing quality management system.
* Apply quality engineering expertise to ensure compliance with regulatory requirements.
* Support certification and maintenance of compliance to ISO 13485 and 21 CFR Part 820.
* Assist with design assurance activities, including design controls, verification, and validation.
* Support development and validation of test methods and computer system assurance programs.
* Participate in risk management and usability engineering activities.
* Maintain document control through an electronic QMS tool and perform related administrative tasks.
* Contribute to the CAPA and non-conformance (NC) investigation and resolution process.
* Assist in internal and external audits and implement corrective actions as needed.
* Support updates and gap assessments for applicable regulatory standards and guidance.
* Participate in supplier quality management, vendor evaluation, and AVL maintenance.
* Collaborate cross-functionally to uphold quality objectives and continuous improvement.
* Perform additional quality-related duties to support business goals and KPIs.
Requirements
* Bachelor's degree in engineering, science, or a related field (or equivalent).
* Minimum of 2 years' experience in a medical device or supplier environment.
* Familiarity with ISO 13485, FDA QSR (21 CFR Part 820), and GMP requirements.
* Experience in both FDA and European regulatory environments is preferred.
* Strong initiative, problem-solving, and follow-through in executing responsibilities.
* Understanding of risk management methodologies (ISO 14971).
* Experience with sterilization (EtO/Gamma), biocompatibility, and transportation testing is a plus.
* Prior involvement in audits or inspections is an advantage.
* Proficiency in MS Office and familiarity with electronic QMS tools.
Key Responsibilities:
As a Quality Engineer I, you will be responsible for ensuring the quality and integrity of our medical devices. This includes applying quality engineering expertise to ensure compliance with regulatory requirements, supporting certification and maintenance of compliance, and assisting with design assurance activities.
What We Offer:
We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and hands-on quality professional looking for a new challenge, we encourage you to apply.