Role Summary:
We are seeking a dedicated Quality Assurance professional to join our team in a 12-month parental leave cover role.
This exciting opportunity is ideal for individuals with experience in administering quality management systems, managing quality documentation, and performing internal and supplier audits.
* Key responsibilities include:
* Administering quality management systems for the business and relevant entities
* Managing quality documentation to meet organizational needs in compliance with ISO 9001 requirements
* Performing internal audits as a lead auditor supporting the internal audit program
* Performing supplier audits as a lead auditor
* Monitoring and supporting timely execution of internal and supplier audits
* Preparing for audits by researching materials, standards, policies, and procedures to formulate a plan of action
* Recruiting, training, and ensuring competency of a team of internal auditors
* Ensuring that non-conformities are recorded and resultant actions are effective
* Identifying and executing opportunities for continuous improvement
* Promoting awareness and understanding of the quality management system
* Designing training resources and providing training for quality-related processes
* Assisting QA management with other functions as required and supporting other elements of a QA system, e.g., non-conformances, process improvements, etc.
Requirements:
* Minimum 2 years' experience in medical device internal or supplier auditing required
* Experience with QMS within the medical device industry
* Significant level of knowledge of the ISO standards (ISO 9001, ISO 13485, ISO 19011)
* Auditing qualifications - Internal auditor or Lead Auditor certification
* Strong background in auditing and quality management systems best practice
* Ability to work well independently and as part of a team
* Expertise in MS Office Suite
* Bachelor's degree in a related field or equivalent work experience preferred
* Familiarity with supplier management process
* Experience with developing and delivering training modules
What We Offer:
We provide a supportive and dynamic work environment with opportunities for career growth and development. If you're passionate about quality and customer satisfaction, we encourage you to apply for this exciting opportunity.