Quality Engineer
Responsibilities:
- Ability to work within a team environment and build relationships across the organisation as well as with external suppliers & regulatory agencies etc.
- Co-ordination of complaint handling Analysis and Investigation activities for a wide range of Medtronic products including receipt and documenting of incoming complaint devices relating to events.
- Perform analysis and investigation, and laboratory duties related to the complaint Analysis and Investigation activities. Assisting in test procedure development and non-routine analyses relating to root cause investigations.
- Co-ordination of cross-functional activities in the investigation of customer complaints and determination of root cause.
- Possess an awareness of the manufacturing process and final products, including terminology associated with the product use and failure modes typically experienced by the customer
- Conduct laboratory support functions, Performs and coordinate instrument maintenance, calibration and alignment checks.
- Communicate key information including escalation of Quality Issues to the CQXM Management and key extended post market quality teams & functional management to ensure full engagement &alignment.
- Contribute to continuous improvement activities to support the role out of cell operating systems and principles within the CQXM department. Delivering cost-down through innovative solutions.
- Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
- Support new product launch as part of the Product Development Process ensuring that CQXM requirements are included in the process.
- Ensure compliance to all applicable department, site-wide procedures and regulations. Support Internal and External audit preparation and activity which includes application and maintenance of quality standards for all activities associated.
- Train and support new analysts.
Requirements:
- Min of a bachelor’s degree (Level 8 NFQ) in a relevant technical discipline (e.g., Engineering, Science)
- Experience in a medical devices or related environment desirable
- Strong interpersonal, communication and organizational skills
- Practical working knowledge of statistical data analysis, problem solving and quality improvement tools and techniques preferable
- Technical writing skills
- Ability to multi-task and to take initiative is essential
- Effective time management skills
- Builds and maintains positive relationships with others; shows respect and consideration for others
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