Background
Our client is an innovative MedTech company specialising in single-use sterile technology products for surgeons. The company 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.
Full time, 5 days per week, on site at Lane Cove West.
Qualifications
* 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.
* Strong analytical and problem‑solving skills.
* Effective written and oral communication.
* Capable of working in a team.
* High level of attention to detail.
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 ISO 13485.
* 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.
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