Quality Assurance Coordinator
WellAir makes the indoor world cleaner and safer. Scientifically proven to harmonize with how we work, live and play.
Bring your talents & abilities with you and join our WellAir team. WellAir's patented technologies mitigate microorganisms that lead to infectious diseases, including viruses, by delivering innovative and powerful air cleaning technology and surface disinfection devices. Our best-in-class solutions are used worldwide in healthcare, education, commercial, industrial, and consumer settings to create healing, learning, and working spaces that foster human health, productivity, and wellbeing. We are now interested in growing our Quality team with the addition of a QA Coordinator.
The Quality Assurance Coordinator will plan, coordinate, and direct the quality system to ensure documentation and standards of quality management system meet ISO 9001 and ISO 13485 standards. The coordinator will ensure that processes needed for quality management are established, implemented and maintained through internal and external audits. This includes:
- Maintaining and implementing processes, procedures, forms, work instructions and tools to monitor and improve Quality Assurance processes.
- Supporting the review and approval of SOPs, work instructions, forms and validation plans from other departments.
- Reviewing and approving documents related to Quality Assurance investigations.
- Support the Quality Management System (QMS).
- Develop and maintain quality assurance objectives in support of company policies and goals.
- Ensure that SOPs, forms, and quality documents are maintained and updated at the revision levels and distributed in quality systems.
- Train teams to reduce quality problems and increase understanding of quality goals.
- Analyse data, create reports and communicate feedback.
- Responsible for the internal quality audit program, ensuring that audits are completed according to schedule and corrective actions are tracked and completed.
- Communicate internally and with customers on complaints and investigations; assist in the preparation of reports on customer complaints, investigations, quality trends, and other quality Key Performance Indicators (KPIs).
- Audit and track supplier quality performance; coordinate Non-Conforming Process for suppliers and internal issues.
- Assist in training employees on the Quality System, Root Cause Analysis (RCA), and various QA standards.
- Document current state, risks, and process improvement goals.
- Other duties may arise based on the evolving needs of the business.
Experience / Requirements:
- Bachelor’s Degree preferred but not essential with equivalent work experience.
- Minimum 3 years of experience in manufacturing within the Quality Control/Quality Assurance environment, preferably in the medical device sector
- ISO certification experience preferred with experience of ISO 9001 and ISO13485.
- Ability to learn new techniques, perform multiple tasks simultaneously and keep accurate records.
- Highly organised and detail oriented with a strong sense of safety awareness.
- Excellent influencing skills at all levels of the organization.
- High level of proficiency with Microsoft programs.
- Ability to travel occasionally.