- At the facility, the company manufacture mainly angioplasty catheters that are used in both coronary and peripheral procedures to unblock arteries.
- We are now recruiting a QA Engineer II (1-year Contract with the possibility of extension).
- The Quality Assurance Engineer will be responsible to assure that all Suppliers, Components and associated activities are appropriately qualified in accordance with local, Corporate and Divisional requirements.
- Performs supplier audits and on-going supplier surveillance as required; Incorporates risk management, performance and validation inputs as well as applicable Standards and Procedures in planning and implementation of supplier activities.
- Represents quality interests and concerns on project teams.
- Participate 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.
- Ensure compliance to quality system requirements as defined by company procedures, 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
- Provide Quality Engineering representation on cross-functional product development teams
- Perform timely disposition of non-conforming materials from: Incoming Quality Control or Manufacturing Processes, to ensure continued material compliance
- Lead cross-functional teams to develop risk assessments and risk controls
- Support development of appropriate product/component specifications and supports development and validation of inspection/test methods
- Support pre-production QA activities and ensures information is adequately transferred during design transfer by interfacing with Operations, Engineering and Validation groups
- Apply risk management, change control, and validation principles throughout the product lifecycle
- Support the divisional corrective / preventive action program by applying root cause analysis and problem-solving techniques and by implementing corrective/preventive actions
- The successful candidate will be educated to degree level in either a Science, Engineering or Technical related field.
- You will have a background in the medical device industry or similar industrial environment with good working knowledge of regulatory requirements and Quality Systems techniques.
- You will have demonstrable experience in risk-based decision making and problem-solving.
- Good analytical capabilities
- Knowledge of design validation, design transfer and change control principles and techniques
- Knowledge of statistical methods and Six Sigma process excellence tools
- Knowledge of risk management principles and techniques
- Knowledge of pre-production QA principles and techniques (e.g. APQP, PPAP, MSA)
- Knowledge of supplier qualification and management principles and techniques (incl. auditing techniques)
- Knowledge of project management fundamentals and tools
- Advanced computer systems skills (MS Office software, databases and statistical software)
- Good teamwork capabilities, effective reporting
- Fluent English communication skills (business English written and oral)
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
14 Danville Business Park, Kilkenny, Ireland
+353 56 77 90100