Quality Assurance Manager required by CareerWise Recruitment for our multinational medical device client in Shannon, County Clare.
The Quality Assurance Manager is responsible for the planning and execution of activities related to the maintenance and development of the Quality Management System (QMS).
Responsibilities:
* Responsible for the management, maintenance and enhancement of the QMS including CAR, NCMR, DCR, Supplier records and Complaints etc.
* Maintain quality metrics for Management review and monthly reviews.
* Support the development and training of new starters, ensuring established quality standards are maintained.
* Responsible for the maintenance of the ISO 13485:2016 requirements.
* Ensure internal audits are completed on schedule, conduct internal audits and be part of the internal auditing team.
* Evaluate internal audit findings and implement effective CAR system.
* Periodically review and edit current quality assurance procedures and develop new QA related procedures and work instructions where needs are identified.
* Lead, coach and develop all personnel within the Quality team to continually improve quality performance, and manufacturing efficiency.
* Proactively evaluates existing and emerging quality requirements and direct implementation of activities to assure compliance to ISO.
Requirements:
* Degree in business, science, or engineering and minimum 3 years prior experience in a leadership Quality Assurance role for a regulated industry: Medical Device/ Pharmaceutical, or 5 years minimum experience in Quality Assurance in Medical Device/Pharmaceutical industry.
* Strong interpersonal and professional skills required in the areas of verbal and written communications, customer focus, service to internal and external customers, training, influencing and team building.
* Proficiency in Microsoft Office applications such as Word, Excel and PowerPoint.
* Experience with ISO 13485:2016.
* Experience in quality system audits.
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