Quality Lab Technican III
Location:
Galway
Duration:
12 Months
Job Type:
Onsite
Our Purpose
In this role, you will focus on complaint handling and post market regulatory reporting activities for a wide range of products. You will be part of a high performing Complaint Handling and Medical Device Regulatory reporting department, which provides value throughout the Product Life cycle through world class execution in Medical Device Reporting and Vigilance compliance.
A Day in The Life Of:
* 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 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.
Key Skills & Experience
* 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
* Lab environment experience is desirable but not essential
* Strong interpersonal, communication and organisational 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
For more information, contact Alan on