– Quality Assurance Manager - Shannon
Are you an experienced Quality Assurance professional looking for a leadership role in a regulated industry? We are seeking a Quality Assurance Manager to oversee and enhance our Quality Management System (QMS), ensuring compliance with industry standards and delivering consistently high-quality products that meet customer requirements.
Key Responsibilities:
* Manage, maintain, and enhance the QMS, including CAR, NCMR, DCR, Supplier Records, and Complaints.
* Track and maintain quality metrics for management and monthly reviews.
* Support the training and development of new starters to uphold established quality standards.
* Ensure compliance with ISO 13485:2016 requirements.
* Conduct and oversee internal audits, evaluate findings, and implement effective Corrective Action Reports (CARs).
* Review, update, and develop quality assurance procedures and work instructions as needed.
* Lead, coach, and develop the Quality team to drive continuous improvement in quality performance and manufacturing efficiency.
* Stay up to date with evolving quality requirements and ensure compliance with industry regulations.
Skills & Experience Required:
* Degree in Business, Science, or Engineering.
* Minimum 3 years of leadership experience in Quality Assurance within a regulated industry (Medical Device/Pharmaceutical) OR 5+ years of experience in Quality Assurance within Medical Device/Pharmaceutical industries.
* Strong communication, team-building, and training skills with a customer-focused mindset.
* Proficiency in Microsoft Office (Word, Excel, PowerPoint).
* Hands-on experience with ISO 13485:2016 and quality system audits.
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