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Quality Manager for Medical Devices

2 weeks ago


Sligo, Sligo, Ireland TN Ireland Full time
Company Overview:

TN Ireland is a leading manufacturer of medical devices, dedicated to delivering high-quality products that meet the needs of healthcare professionals and patients alike. Our commitment to excellence is reflected in our rigorous quality control processes, which ensure that every product that leaves our facility meets the highest standards of safety and efficacy.

About the Job:

We are seeking a highly skilled Quality Engineer to join our team at TN Ireland. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of quality and compliance in the development and manufacture of medical devices.

Key Responsibilities:
- Provide technical quality support to project managers, design engineers, production managers, and clients.
- Work closely with the engineering team and clients to establish and maintain compliant product specifications.
- Conduct quality reviews of process validation plans, protocols, and reports.

Required Skills and Qualifications:
  1. Minimum degree in a science or engineering discipline.
  2. At least 3-5 years' experience working in a medical device environment.
  3. Strong knowledge of ISO 13485, FDA regulations (21 CFR 820), and MDR requirements.
  4. Excellent written and verbal communication skills, with the ability to communicate appropriately with different engineering teams, project management, suppliers, and customers.