|Job Ref No.:||1027|
|Job Title:||Quality Engineer Enniscorthy|
|Experience Required||Please see job description|
|Qualifications Required||Minimum Engineering of Science Degree|
The successful candidate must be able to apply quality engineering principles and techniques to ensure that the products developed and manufactured by the division meet or exceed performance specifications and regulatory standards.
Participates in day to day quality operations to ensure conforming materials are available for manufacturing. Works on problem solving and investigations to determine root cause of material non-conformances so that issues are resolved to close out with no recurrences.
Ensures compliance to quality system requirements, FDA QSR, ISO 13485 and applicable international and national standards (e.g. EN, ASTM) through active participation in the divisional and cross divisional product and process development system.
Provides Quality Engineering representation on cross-functional product development teams.
Performs timely disposition of non-conforming materials from: Incoming Quality Control or Manufacturing Processes, to ensure continued material compliance.
Leads cross-functional teams to develop risk assessments and risk controls.
Supports development of appropriate product/component specifications and supports development and validation of inspection/test methods.
Supports pre-production QA activities and ensures information is adequately transferred during design transfer by interfacing with Operations, Engineering and Validation groups.
Applies risk management, change control, and validation principles throughout the product lifecycle.
The successful candidate must have a minimum of a engineering or science degree required
Experience in medical device industry or similar industrial environment (areas see above) with good working knowledge of regulatory requirements and Quality Systems techniques and experience in risk-based decision making and problem-solving.