Sr. Specialist - QA and RA

We are seeking a skilled Quality and Regulatory Assurance Specialist to contribute expertise in healthcare diagnostic equipment manufacturing, ensuring seamless regulatory compliance, upholding rigorous quality standards, and actively shaping advancements in medical technology

Client Details

Our client are a global manufacturer of diagnostic healthcare products. With an impressive presence internationally this role presents a huge opportunity to grow and develop your career with a true market leader.

Description

• Ensure the QMS is maintained effectively in compliance to ISO13485 standard, policies and the local regulatory requirements
• Lead the internal audit and external audit, including the audit/inspection by regulatory authority and notify body
• Manage NC and Stop Shipment as per requirements
• Timely restrict/un-restrict products in SAP system, and inform LSP to physical
• Quarantine/release the products with defects and/or under stop shipment
• Timely coordinate the disposition of non-conforming products
• Lead training development for all the quality related training, and review it at least once a year;
• Build up quality improvement capabilities and maintain a quality training system
• provide quality training, including but not limited to quality sops/wis;
• Management of suppliers and distributors, focus on the critical ones

Profile

• In-depth understanding of relevant regulations and standards in the industry
• Expertise in adhering to ISO 13485 standards to maintain a robust quality framework.
• Exceptional attention to detail in maintaining accurate and compliant documentation, including technical files, design history files, and regulatory submissions.
• Effective communication and collaboration with cross-functional teams, including R&D, manufacturing, and clinical affairs, to integrate regulatory considerations seamlessly into product development and manufacturing processes.
• Skillful application of risk management principles to assess and mitigate potential hazards
• Ability to navigate and adapt to evolving regulatory landscapes
• Strong problem-solving skills to address complex regulatory challenges and find innovative solutions
• Clear and concise communication skills

Job Offer

• Join a dynamic team at the forefront of revolutionising health care
• Be part of a collaborative and inclusive workplace
• Be given access to opportunities internationally to develop your career in QA & RA

To apply online please click the 'Apply' button below. For a confidential discussion about this role please contact Bree Chapman on +61 3 8616 6234.