The Company Our client is an Australian biotechnology screening and diagnostic company, dedicated to achieving early and accurate breast cancer diagnoses. The company's primary focus is on facilitating early intervention, ultimately leading to improved outcomes for women.
The Opportunity Due to growth, our client is seeking a new Quality Manager. You will be responsible for the maintenance of a Quality Management System compliant to all relevant standards including ISO15189, ISO13485, TGA and other required certifications. You will lead and coordinate the analysis of business processes and procedures to ensure ongoing quality assurance across the organisation. Your role includes the following deliverables:
Management of the electronic Quality Management System (eQMS) including change management.Develop, implement, and maintain quality and compliance systems in alignment with regulatory requirements and industry standards.Stay abreast of industry trends and best practices to proactively update and enhance quality systems.Assist in the identification of key operational risks and develop risk mitigation strategies.Monitor incidents, near misses, and hazards received, ensuring the appropriate investigation, corrective action and systemic improvement is undertaken.Engage and collaborate with various stakeholders to identify areas for improvement and implement corrective actions as necessary.Management and conducting of internal audit programs.Reviewing and developing policies and procedures, implement corrective actions, and ensure ongoing compliance.Investigate complaints, quality issues, and escalate serious incidents.Position Requirements Sc. (or equivalent) and approximately 5+ years of experience with Quality Systems.Knowledge and demonstrated experience with ISO15189, ISO13485, TGA and other Standards.Experience in policy, procedure, administration, maintenance, and improvement documents.Demonstrated capability in the improvement of systems, processes, and frameworks in a laboratory environment.Ability to communicate and collaborate cross functionally with all internal stakeholders to meet deadlines.Clear communication skills, comfortable with public speaking with skill and confidence.Provides proactive, high-quality service to both internal and external stakeholders; delivers what is promised on time; sets high standards for quality consistency.Must be able to work flexible hours to meet business requirements.The Offer To learn more about this exciting opportunity, please email any questions you may have to or call to arrange a confidential discussion with Mark Thomas or Marilyn Jones. To apply, visit our website at www.mexec.com and click Apply Now to submit a copy of your current CV and cover letter.
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