– Quality Assurance Manager - Shannon

Are you an experienced Quality Assurance professional looking for a leadership role in a regulated industry? We is 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.

Interested in applying?