Job Description
The Quality Assurance Manager is a key role within our organisation, responsible for the planning and execution of activities related to the maintenance and development of 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 reviews.
* Support the development and training of new starters, ensuring established quality standards are maintained.
* Responsible for the maintenance of the ISO requirements.
* Ensure internal audits are completed on schedule, conduct internal audits, and be part of the internal auditing team.
* Evaluate internal audit findings and implement an effective CAR system.
* Periodically review and edit current quality assurance procedures and develop new QA-related procedures and work instructions where needs are identified.
* Lead, coach, and develop all personnel within the Quality team to continually improve quality performance and manufacturing efficiency.
Requirements:
* Degree in Business, Science, or Engineering.
* Minimum 3 years prior experience in a leadership Quality Assurance role for a regulated industry: Medical Device/Pharmaceutical.
* Or 5 years minimum experience in Quality Assurance in Medical Device/Pharmaceutical industry.
* Strong interpersonal and professional skills required in verbal and written communications, customer focus, service to internal and external customers, training, influencing, and team building.
* Proficiency in Microsoft Office applications such as Word, Excel, and Power Point.
* Experience with ISO and quality system audits.