Quality Tech – Complaints - Galway

Desired Skills: complaints,investigations,audit

PE Global is currently recruiting for Quality Tech – Complaint RPA Lab on behalf of our client based in Galway. This is an initial 12 month contract role and will be onsite.

Job is on site, in the CQXM – RPA Lab (Complaint returned product analysis lab)

Purpose

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.
• Train and support new analysts.

• 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 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

Interested candidates should send their CV to Audrey at audrey.mccarthy@peglobal.net or call 0214297900