JO-2605-565569
Location: Enniscorthy, Co. Wexford
Type: 12 months FTC.
Our client, a high volume medical device manufacturing facility, requires a Design Quality Engineer to support new product development and product introduction activities on-site.
Role
Manage and allocate Quality Engineering resources for New Product Development (NPD) and New Product Introduction (NPI) programs
Ensure compliance with all applicable regulatory requirements, standards, and procedures
Provide Quality Engineering support for test method validation, product verification and validation, reliability testing, and statistical data analysis
Oversee component qualifications, process capability studies, equipment qualifications, and process validations
Facilitate and ensure compliance with risk management activities, supporting NPD/NPI teams in generating and maintaining risk files
Support field assurance investigations and post-market surveillance activities as required
Collaborate closely with R&D and Engineering to enable successful execution of the product development lifecycle and robust product launches
Review and approve validation documentation and risk management files; participate in regulatory, corporate, and third-party audits
Support regulatory submissions, promote a positive teamwork culture, and contribute to additional projects as assigned
Requirements
Third-level degree in Engineering, Science, or a related technical discipline
Minimum of 3+ years' experience in Class II or Class III medical devices.
Experience working in a highly regulated environment (medical device, pharmaceutical, or life sciences)
Strong knowledge of quality and regulatory standards, including QSR, ISO 13485, ISO 14971, MDD/MDR, MDSAP, 21 CFR, and applicable ICH guidelines
Hands‑on experience with design, process, equipment, test method, and software validation activities
Proficiency in Quality Engineering tools such as risk management, root cause analysis, statistics, sampling plans, and process capability studies
Experience supporting new product development and commercialization, including risk assessments and component qualification
Proven experience conducting and supporting quality and regulatory audits
What's On Offer
5% Bonus
VHI healthcare
Pension
Educational assistance availability for career progression or career alignment.
Company EAP service
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