Quality Engineer
Responsibilities:
* Collaborate with a team to build relationships within the organization and with external suppliers, regulatory agencies, and other stakeholders.
* Coordinate complaint handling analysis and investigation activities for Medtronic products, including receiving and documenting incoming complaint devices related to events.
* Perform analysis and investigation tasks, as well as laboratory duties, in support of complaint analysis and investigation activities. Assist in developing test procedures and conducting non-routine analyses for root cause investigations.
* Coordinate cross-functional activities to investigate customer complaints and determine root causes.
* Maintain awareness of manufacturing processes and final products, including product use terminology and typical failure modes experienced by customers.
* Conduct laboratory support functions, perform instrument maintenance, calibration, and alignment checks.
* Communicate critical information, including quality issues, to CQXM Management, extended post-market quality teams, and functional management to ensure engagement and alignment.
* Contribute to continuous improvement initiatives to implement cell operating systems and principles within the CQXM department. Identify cost-saving opportunities through innovative solutions.
* Ensure corrective measures meet acceptable reliability standards and documentation complies with requirements.
* Support new product launches as part of the Product Development Process, ensuring CQXM requirements are incorporated.
* Comply with applicable department, site-wide procedures, and regulations. Support internal and external audits, including maintaining quality standards for all associated activities.
* Train and support new analysts.
Requirements:
* Bachelor's degree (Level 8 NFQ) in a relevant technical field (e.g., Engineering, Science)
* Experience in medical devices or a related environment is desirable.
* Strong interpersonal, communication, and organizational skills.
* Practical knowledge of statistical data analysis, problem-solving, and quality improvement tools and techniques.
* Technical writing skills.
* Ability to multitask and take initiative is essential.
* Effective time management skills.
* Builds and maintains positive relationships with others; shows respect and consideration for others.