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Quality Assurance Manager
Required by CareerWise Recruitment for our multinational medical device client in Shannon, County Clare. The Quality Assurance Manager is responsible for planning and executing activities related to maintaining and developing the Quality Management System (QMS).
Responsibilities
* Manage, maintain, and enhance the QMS, including CAR, NCMR, DCR, supplier records, and complaints.
* Maintain quality metrics for management review and monthly reports.
* Support the development and training of new staff, ensuring quality standards are upheld.
* Ensure compliance with ISO 13485:2016 requirements.
* Complete internal audits on schedule, conduct audits, and participate in the internal auditing team.
* Evaluate audit findings and implement effective Corrective Action and Preventive Action (CAPA) systems.
* Review and update existing quality assurance procedures and develop new QA procedures and work instructions as needed.
* Lead, coach, and develop the Quality team to improve quality performance and manufacturing efficiency.
* Proactively evaluate emerging quality requirements and implement activities to ensure compliance with ISO standards.
Requirements
* Degree in business, science, or engineering, with a minimum of 3 years in a leadership Quality Assurance role in a regulated industry (Medical Device/Pharmaceutical), or at least 5 years of QA experience in the Medical Device/Pharmaceutical industry.
* Strong interpersonal and professional skills, including communication, customer focus, training, influencing, and team building.
* Proficiency in Microsoft Office applications such as Word, Excel, and PowerPoint.
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