Job Title: Senior Quality Engineer
We are seeking a highly skilled Senior Quality Engineer to join our client, a medical device engineering company based in Limerick.
About the Role:
* Develop specifications, CTQ maps, test methods, and validate processes to ensure product quality.
* Manage complaints, non-conformities, risks, and corrective actions to maintain quality standards.
* Oversee supplier quality management and product release processes.
* Lead quality planning, testing, and audit activities for products.
* Represent the company in customer interactions and ensure customer requirements are met within the quality management system.
* Collaborate with the new product development team for smooth transition to production.
* Identify and implement continuous improvements across the organization.
Requirements:
* Minimum 5 years of direct QMS experience.
* Validation, MSA, and Gauge R&R experience.
* Strong written and oral communication skills.
* Experience working with medical device regulations is desirable.
* Good computer skills in MS Office Suite.
* Working knowledge of EN ISO 13485, FDA QSR 21 CFR Part 820, and GMP principles.
Salary:
$80,000 - $110,000 per annum (dependent on experience).