Quality Assurance Manager
4 days ago
– 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.
- 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.
- 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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