Product Quality Engineer
Location: Lane Cove West 2066
About:
Our client is an innovative MedTech company specialising in single-use sterile technology products for surgeons is gearing up for global expansion, building on its early sales success in Australia and Japan.
They are looking for a Product Quality Engineer who will be responsible for ensuring that contract manufacturers produce high-quality product compliant with ISO 13485:2016, MDSAP, and applicable regulatory standards and for setting up and overseeing new internal manufacturing processes as the company grows.
Technical qualifications and experience:
* Bachelor's degree or equivalent,
* Proven experience in the application of ISO 13485 and medical device manufacturing,
* Proven experience in Quality Engineering within the medical device industry, with a strong emphasis on simplifying and streamlining procedures.
* Experience working in a manufacturing/clean room environment and managing asset management processes.
Skills: Strong analytical and problem-solving skills,
* Effective written and oral communication
* Capable of working in a team
* High level of attention to detail
About the role:
* Full time 5 days per week.
* On site at Lane Cove West.
Responsibilities:
* Develop and enforce quality control procedures throughout the production process to ensure consistent product standards,
* Participate in risk management efforts, identifying and addressing potential quality risks,
* Conduct validations for Quality Management System Software and support verification and validation activities to enhance the QMS,
* Assist in the implementation, monitoring, and upkeep of Quality Management System (QMS), ensuring alignment with ISO 13485:2016, MDSAP, and relevant regulatory standards,
* Supervise internal manufacturing assembly process, including training temporary staff, to ensure efficient production and maintain product quality,
* Manage and enhance asset management processes to optimise the use and maintenance of equipment and resources,
* Manage non-compliance issues (e.g., non-conformance reports, CAPA), ensuring timely corrective actions,
* Manage suppliers and related issues (e.g. Supplier Corrective Action Requests).
* Complete Internal audits and participate/lead third-party audit (Customer, Regulatory/Notified Body) in accordance with ISO13485
* Participate in updating medical technical files, post-market surveillance activities and undertake additional tasks as directed by the QA Manager,
* Serve as the Document Controller, ensuring accurate and compliant record-keeping for audit readiness,
* Address customer feedback and complaints, ensuring proper documentation and resolution.
* Support Management Reviews and Quality Assurance meetings to ensure the continued effectiveness of the QMS.
If this opportunity resonates with you, we invite you to apply.