The Quality Manager is responsible for overseeing and enhancing the Quality Management System (QMS) to ensure operational excellence and regulatory compliance.
This role plays a critical part in maintaining internal policies and procedures, ensuring our Global client consistently delivers high-quality products that meet industry standards and customer expectations.
This is a role which will be well supported by the Head of Quality, but requires a self-starter who can work off their own initiative.
Key Responsibilities:
Manage, maintain, and improve the QMS, overseeing key processes such as Corrective and Preventive Actions (CAR), Non-Conformance Management (NCMR), Document Change Requests (DCR), supplier records, and customer complaints.
Track and analyze quality metrics, preparing reports for management and monthly reviews.
Facilitate onboarding and training of new employees, ensuring adherence to established quality protocols.
Ensure compliance with ISO 13485:2016 requirements, including documentation and audit preparedness.
Coordinate and conduct internal audits, ensuring timely completion and supporting the internal audit team.
Analyze audit findings and drive the implementation of corrective actions for continuous improvement.
Review, refine, and develop new quality procedures and work instructions based on operational needs.
Mentor and guide the Quality team, fostering a culture of continuous improvement and operational efficiency.
Monitor evolving regulatory and quality standards, implementing necessary changes to maintain compliance with industry requirements.
Qualifications & Skills:
Bachelor's degree in Business, Science, or Engineering, with at least 3 years of leadership experience in Quality Assurance within a regulated industry (Medical Device/Pharmaceutical) or 5+ years in a Quality Assurance role in Medical Device/Pharmaceutical manufacturing.
Strong communication skills, with the ability to train, influence, and collaborate across teams.
Proficiency in Microsoft Office (Word, Excel, PowerPoint) and experience managing quality data.
Hands-on experience with ISO 13485:2016 compliance and implementation.
Background in quality system audits, including conducting audits and implementing corrective actions.
This role is ideal for an experienced quality professional who is passionate about regulatory compliance, process improvement, and ensuring the highest product quality standards in a fast-paced environment.
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