Qa/Qc Officer - Medical Device

About The Company:

Our client is a leading Medical Device manufacturer dedicated to improving the lives of patients. They are committed to developing high quality innovative products.

We are seeking an experienced Quality Control Officer to join our client's team at their manufacturing facility in Lane Cove West industrial park. This person will play a fundamental role in ensuring product's high quality and compliance with ISO 13485.

Responsibilities:

• Conducting inspections and testing of raw materials, components, and finished products to ensure they meet quality specifications and standards,

• Investigating and documenting any deviations or non-conformances in the manufacturing process or product quality, and implementing corrective and preventive actions,
• Managing and maintaining quality documentation, including specifications, procedures, and records related to manufacturing and testing processes,
• Ensuring that all manufacturing processes comply with regulatory requirements and quality standards,
• Providing training to personnel involved in quality control activities and ensuring adherence to quality policies and procedures,
• Participating in risk management activities, including identifying, assessing, and mitigating risks associated with product quality and regulatory compliance,
• Identifying opportunities for process improvement and implementing initiatives to enhance quality, efficiency, and compliance within the organization.

Qualifications and experience:

• Experience working with ISO 7 regulated cleanrooms,
• Previous knowledge of ISO 13485 requirements,
• High level of attention to detail,
• Strong analytical and problem-solving skills,
• Ability to work in a fast-paced environment,
• Effective written and oral communication,
• Competent in Microsoft Office,
• Unrestricted Australian working rights is a must.